55 Quality Management jobs in Ireland
Director, Quality Risk Management
Dublin, Leinster
Bristol Myers Squibb
Posted today
Job Viewed
Job Description
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Summary**
The Director, Quality Risk Management will drive consistent Global Leadership on Quality Risk Management (QRM), the Risk Management Framework, Risk Posture considerations and provide support for key QRM processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. Accountable to drive QRM process optimization, integration, adoption and continuous improvement through capability building, key stakeholder engagement, digital enhancement, trend analysis of QRM data and guidance on authoring QRM procedures. Works cross-functionally to develop performance improvement initiatives throughout the organization by interacting and working with many great teams and leaders across the BMS network.
This position will report into the Senior Director, Risk Management.
**Key Responsibilities:**
+ Provide strategic and tactical leadership for establishing and maintaining robust QRM programs across the BMS QMS Level 1 and 2 processes and sub-processes, end-to-end product lifecycle and across all BMS in alignment with relevant governmental regulations and guidelines.
+ Drive process design, simplification, deployment, maintenance, monitoring and improvement of QRM procedures and methodologies (tools). Provide oversight for the management of all changes being planned and executed in these processes.
+ In partnership with the Senior Director, Risk Management, champion the E2E, across product lifecycle QRM Framework and strategic roadmap.
+ Develop and Drive enhancement on digital QRM mapping. Lead execution digital roadmap.
+ Develop Risk Tolerance statements, risk acceptance statements and guiding principles for BMS QRM related risk posture.
+ Lead Risk identification and risk communication/reporting for governance meetings, such as Quality management reviews and Enterprise Risk Management and support managing emerging risks to support business objectives.
+ Lead and support to teams in implementing risk management capabilities and process elements
+ Provide guidance and coaching for the Risk Management Team.
+ Lead the QRM training framework and certification program design & oversee deployment.
+ Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this enhance QRM maturity.
+ Stakeholder Partnering and Engagement: Lead the partnership with teams across BMS for stakeholder-oriented incorporation/improvement of QRM principles and appropriate risk-based approaches into the business processes of the Quality Management System enterprise-wide.
+ Co-chair with the Senior Director, Risk Management, QRM specific governance and oversight forums.
+ Business support: Drive process monitoring/adoption and GxP risk profiles through overseeing data collection, analysis, trending and reporting of QRM dashboards in collaboration with I&T .
+ Stay updated with industry best practices and regulatory requirements related to QRM communicate within BMS and adapt internal processes effectively.
+ Works across regulator/industry boundaries to become a QRM industry leader, find common solutions, and drive positive impact and benefits for patients.
+ Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM processes.
+ Provide direction and critical input for setting metrics and monitoring and evaluating the effectiveness of QRM initiatives, and recommend improvements as needed.
+ Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
+ Oversee the process design for managing major disruptions to the GxP business including how to respond in a Risk Based manner (incorporating QRM principles, tools and processes into the response)
+ Provide leadership, coaching, and training for members of the QRM Community of Practice and other QRM practitioners including both the technical processes and the behaviors necessary to optimize process execution.
+ Support the testing and roll out of IT systems supporting QRM processes and data analytics.
**Qualifications & Experience:**
+ Master's degree in pharmaceutical sciences, engineering, biology, or other related discipline or equivalent combination of education and experience.
+ A minimum of 15 years of biopharmaceutical/pharmaceutical industry experience with at least 3 years in risk management leadership position.
+ Expertise in GMP compliance, Quality System and global GMP regulations
+ Must have strong knowledge and expert understanding using different QRM tools for the different GXP areas (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP).
+ Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
+ Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
+ Demonstrated influential leadership expertise and experience with senior level interactions.
+ Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively
+ Enterprise mindset to be able to think and act across functions and divisions.
+ Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
+ Strong leadership and project management skills, with the ability to lead cross-functional teams.
+ Expert-level knowledge and experience using data to drive understanding, decisions, and recommendations.
+ Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
+ Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
+ Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines.
+ Travel: Ability to travel 10-25% as needed
**GPS_2025 GQ_2025**
The starting compensation for this job is a range from $187,700 to $227,400, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1593133
**Updated:** 2025-07-17 04:03:53.159 UTC
**Location:** Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Summary**
The Director, Quality Risk Management will drive consistent Global Leadership on Quality Risk Management (QRM), the Risk Management Framework, Risk Posture considerations and provide support for key QRM processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. Accountable to drive QRM process optimization, integration, adoption and continuous improvement through capability building, key stakeholder engagement, digital enhancement, trend analysis of QRM data and guidance on authoring QRM procedures. Works cross-functionally to develop performance improvement initiatives throughout the organization by interacting and working with many great teams and leaders across the BMS network.
This position will report into the Senior Director, Risk Management.
**Key Responsibilities:**
+ Provide strategic and tactical leadership for establishing and maintaining robust QRM programs across the BMS QMS Level 1 and 2 processes and sub-processes, end-to-end product lifecycle and across all BMS in alignment with relevant governmental regulations and guidelines.
+ Drive process design, simplification, deployment, maintenance, monitoring and improvement of QRM procedures and methodologies (tools). Provide oversight for the management of all changes being planned and executed in these processes.
+ In partnership with the Senior Director, Risk Management, champion the E2E, across product lifecycle QRM Framework and strategic roadmap.
+ Develop and Drive enhancement on digital QRM mapping. Lead execution digital roadmap.
+ Develop Risk Tolerance statements, risk acceptance statements and guiding principles for BMS QRM related risk posture.
+ Lead Risk identification and risk communication/reporting for governance meetings, such as Quality management reviews and Enterprise Risk Management and support managing emerging risks to support business objectives.
+ Lead and support to teams in implementing risk management capabilities and process elements
+ Provide guidance and coaching for the Risk Management Team.
+ Lead the QRM training framework and certification program design & oversee deployment.
+ Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this enhance QRM maturity.
+ Stakeholder Partnering and Engagement: Lead the partnership with teams across BMS for stakeholder-oriented incorporation/improvement of QRM principles and appropriate risk-based approaches into the business processes of the Quality Management System enterprise-wide.
+ Co-chair with the Senior Director, Risk Management, QRM specific governance and oversight forums.
+ Business support: Drive process monitoring/adoption and GxP risk profiles through overseeing data collection, analysis, trending and reporting of QRM dashboards in collaboration with I&T .
+ Stay updated with industry best practices and regulatory requirements related to QRM communicate within BMS and adapt internal processes effectively.
+ Works across regulator/industry boundaries to become a QRM industry leader, find common solutions, and drive positive impact and benefits for patients.
+ Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM processes.
+ Provide direction and critical input for setting metrics and monitoring and evaluating the effectiveness of QRM initiatives, and recommend improvements as needed.
+ Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
+ Oversee the process design for managing major disruptions to the GxP business including how to respond in a Risk Based manner (incorporating QRM principles, tools and processes into the response)
+ Provide leadership, coaching, and training for members of the QRM Community of Practice and other QRM practitioners including both the technical processes and the behaviors necessary to optimize process execution.
+ Support the testing and roll out of IT systems supporting QRM processes and data analytics.
**Qualifications & Experience:**
+ Master's degree in pharmaceutical sciences, engineering, biology, or other related discipline or equivalent combination of education and experience.
+ A minimum of 15 years of biopharmaceutical/pharmaceutical industry experience with at least 3 years in risk management leadership position.
+ Expertise in GMP compliance, Quality System and global GMP regulations
+ Must have strong knowledge and expert understanding using different QRM tools for the different GXP areas (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP).
+ Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
+ Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
+ Demonstrated influential leadership expertise and experience with senior level interactions.
+ Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively
+ Enterprise mindset to be able to think and act across functions and divisions.
+ Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
+ Strong leadership and project management skills, with the ability to lead cross-functional teams.
+ Expert-level knowledge and experience using data to drive understanding, decisions, and recommendations.
+ Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
+ Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
+ Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines.
+ Travel: Ability to travel 10-25% as needed
**GPS_2025 GQ_2025**
The starting compensation for this job is a range from $187,700 to $227,400, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1593133
**Updated:** 2025-07-17 04:03:53.159 UTC
**Location:** Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
This advertiser has chosen not to accept applicants from your region.
0
Quality Systems Engineer
Galway, Connacht
Celestica
Posted 7 days ago
Job Viewed
Job Description
Req ID: 126682
Remote Position: No
Region: Europe
Country: Ireland
State/Province: Galway
City: Galway
**General Overview**
**Functional Area:** Quality (QUA)
**Career Stream:** Operations Quality (OPQ)
**Role:** Specialist (SPE)
**Job Title:** Specialist, Operations Quality
**Job Code** : SPE-QUA-OPQ
**Job Level:** Band 08
**Direct/Indirect Indicator:** Indirect
**Summary**
We are currently recruiting for a Systems Quality Engineer as part of our team in Galway.
**Who we are and what we do?**
Celestica is an Equal Opportunities Employer.
Celestica enables the world's best brands. Through our unrivalled customer-centric approach, we partner with leading companies in aerospace and defence, communications, enterprise, health-tech, industrial, capital equipment, and smart energy to deliver solutions for their most complex challenges. With talented teams across North America, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica Galway are a leader in automated manufacturing services with proven expertise in delivering scalable manufacturing solutions throughout the product lifecycle. Celestica Galway supports and provides Automated Technology Solutions & Health-tech Solutions for a number of customers including the Medical Device space.
**Your next challenge will be.**
Lead process/procedure definition and maintain a continuous flow of high-quality products to our customers in a contract manufacturing environment including regulatory content for the latest and more innovative medical devices. This position will be responsible for supporting some of our product family in both the Med tech and Industrial sectors liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager.
**Detailed Description**
Your day-to-day activities will include the following.
+ Manage performance of reports
+ Customer liaison for quality escalations and daily quality issues ensuring measured, developed and timely responses to the customer.
+ Support the change management process and Customer requests as appropriate.
+ High level of competence using relevant corrective action systems (e.g., CAPA)
+ Create concise and accurate technical reports, communicate results and manage subsequent analysis queries
+ Continually seek to drive improvements in product and process quality.
+ Create and evaluate metrics to drive the quality improvement processes.
+ Own, Maintain and report timely and accurate KPI's
+ Create, and update, Procedures and Work Instructions
+ Manage and maintain the NCMR database and report weekly to the customer.
+ Using appropriate statistical techniques to monitor process performance (e.g.SPC, Minitab, Ppk, Gage R & Ranalysis, sampling techniques).
+ Provide quality engineering support to the facility, including validation and risk management and review of technical documentation (eg. FMEA's, control plans)
+ Ability to design tests, evaluate results and recommend solutions to improve the processes associated with our manufacturing.
**Conditions of Employment**
+ Market-competitive total reward: Company Performance bonus program, company pension and health insurance.
+ The opportunity to become a key member of the new product introduction team in the Health Tech Quality function driven by innovation where creativity matters.
+ Training and development opportunities, with us the sky is the limit!
+ The opportunity to innovate, learn, mentor others and work toward your own vision of career success
+ A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities
+ A sustainable culture where we provide opportunities for employees to give back to the community
**Knowledge/Skills/Competencies**
+ Strong knowledge of quality tools, ISO / QMS standards and processes (ISO 9001, ISO13485)
+ Knowledge of data analysis and presentation software and its uses in generating reports, capturing data and presenting data in an understandable format.
+ Strong knowledge of product and manufacturing processes and materials properties
+ Knowledge and understanding of the manufacturing environment and how decisions impact customer satisfaction product quality, on-time delivery and profitability of the unit
+ Knowledge of quality tools such as FMEA, PMP, SPC, 8D methodology, etc.
+ Knowledge of Six sigma and Lean Kaizen.
+ Ability to effectively communicate with a wide variety of internal and external customers to summarize complex technical issues
+ Knowledge of Med-tech and regulatory requirements (such as FDA and MDR) is a requirement of the role with pharma & food safety systems an advantage
+ Ability to effectively lead and manage several projects simultaneously and coordinate multiple, changing deadlines while also working effectively on their own and in a team environment.
+ Ability to be an Internal Auditor
**Typical Education**
+ Bachelor's degree in related field
+ 6 years or more experience in a manufacturing environment within a Quality function
+ Experience in a Med-tech environment is essential
+ Experience of 6 Sigma quality methods would be a distinct advantage.
+ Materials engineering experience/quality materials testing knowledge is an advantage
+ Experience of leading a team is an advantage.
**Notes**
This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
**COMPANY OVERVIEW:**
Celestica (NYSE, TSX: CLS) enables the world's best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development - from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
Remote Position: No
Region: Europe
Country: Ireland
State/Province: Galway
City: Galway
**General Overview**
**Functional Area:** Quality (QUA)
**Career Stream:** Operations Quality (OPQ)
**Role:** Specialist (SPE)
**Job Title:** Specialist, Operations Quality
**Job Code** : SPE-QUA-OPQ
**Job Level:** Band 08
**Direct/Indirect Indicator:** Indirect
**Summary**
We are currently recruiting for a Systems Quality Engineer as part of our team in Galway.
**Who we are and what we do?**
Celestica is an Equal Opportunities Employer.
Celestica enables the world's best brands. Through our unrivalled customer-centric approach, we partner with leading companies in aerospace and defence, communications, enterprise, health-tech, industrial, capital equipment, and smart energy to deliver solutions for their most complex challenges. With talented teams across North America, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica Galway are a leader in automated manufacturing services with proven expertise in delivering scalable manufacturing solutions throughout the product lifecycle. Celestica Galway supports and provides Automated Technology Solutions & Health-tech Solutions for a number of customers including the Medical Device space.
**Your next challenge will be.**
Lead process/procedure definition and maintain a continuous flow of high-quality products to our customers in a contract manufacturing environment including regulatory content for the latest and more innovative medical devices. This position will be responsible for supporting some of our product family in both the Med tech and Industrial sectors liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager.
**Detailed Description**
Your day-to-day activities will include the following.
+ Manage performance of reports
+ Customer liaison for quality escalations and daily quality issues ensuring measured, developed and timely responses to the customer.
+ Support the change management process and Customer requests as appropriate.
+ High level of competence using relevant corrective action systems (e.g., CAPA)
+ Create concise and accurate technical reports, communicate results and manage subsequent analysis queries
+ Continually seek to drive improvements in product and process quality.
+ Create and evaluate metrics to drive the quality improvement processes.
+ Own, Maintain and report timely and accurate KPI's
+ Create, and update, Procedures and Work Instructions
+ Manage and maintain the NCMR database and report weekly to the customer.
+ Using appropriate statistical techniques to monitor process performance (e.g.SPC, Minitab, Ppk, Gage R & Ranalysis, sampling techniques).
+ Provide quality engineering support to the facility, including validation and risk management and review of technical documentation (eg. FMEA's, control plans)
+ Ability to design tests, evaluate results and recommend solutions to improve the processes associated with our manufacturing.
**Conditions of Employment**
+ Market-competitive total reward: Company Performance bonus program, company pension and health insurance.
+ The opportunity to become a key member of the new product introduction team in the Health Tech Quality function driven by innovation where creativity matters.
+ Training and development opportunities, with us the sky is the limit!
+ The opportunity to innovate, learn, mentor others and work toward your own vision of career success
+ A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities
+ A sustainable culture where we provide opportunities for employees to give back to the community
**Knowledge/Skills/Competencies**
+ Strong knowledge of quality tools, ISO / QMS standards and processes (ISO 9001, ISO13485)
+ Knowledge of data analysis and presentation software and its uses in generating reports, capturing data and presenting data in an understandable format.
+ Strong knowledge of product and manufacturing processes and materials properties
+ Knowledge and understanding of the manufacturing environment and how decisions impact customer satisfaction product quality, on-time delivery and profitability of the unit
+ Knowledge of quality tools such as FMEA, PMP, SPC, 8D methodology, etc.
+ Knowledge of Six sigma and Lean Kaizen.
+ Ability to effectively communicate with a wide variety of internal and external customers to summarize complex technical issues
+ Knowledge of Med-tech and regulatory requirements (such as FDA and MDR) is a requirement of the role with pharma & food safety systems an advantage
+ Ability to effectively lead and manage several projects simultaneously and coordinate multiple, changing deadlines while also working effectively on their own and in a team environment.
+ Ability to be an Internal Auditor
**Typical Education**
+ Bachelor's degree in related field
+ 6 years or more experience in a manufacturing environment within a Quality function
+ Experience in a Med-tech environment is essential
+ Experience of 6 Sigma quality methods would be a distinct advantage.
+ Materials engineering experience/quality materials testing knowledge is an advantage
+ Experience of leading a team is an advantage.
**Notes**
This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
**COMPANY OVERVIEW:**
Celestica (NYSE, TSX: CLS) enables the world's best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development - from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
This advertiser has chosen not to accept applicants from your region.
1
Manager Quality Systems
Westport, Connacht
AbbVie
Posted 7 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are currently hiring a Quality Systems Manager to join our team in Westport for a 6 month fixed term contract. The Quality Systems Manger is responsible for the processing of all electronic documentation and printing of controlled documents for Batch Records for the Westport site. The DCC and Quality Batch Issuance Department must maintain compliance with local, regulatory and legislative requirements with regards to Safety, Housekeeping, GMP and support and comply with internal environmental health and safety requirements, procedures and policies. It achieves these functions by interaction with QA, EHS, Compliance and regulatory affairs to ensure all internal procedures reflect current requirements.
Responsibilities:
+ Management of the Document Control and Quality Batch Issuance Teams.
+ Management of SOP, Manufacturing and QA Type Documents onsite.
+ Hosting of Team Tier Board.
+ Priority Scheduling.
+ Collection of metrics for DCC and Quality Batch Issuance Departments.
+ Processing of team GTW records.
+ Oversight of addition of SOPs to LMS Compliance Wire.
+ Approval of DCC related SOPs and internal documentation.
+ Co-ordination of file retention activities onsite.
+ Site Representation for Global Documentation Projects.
+ Co-Ordination of Global Documentation updates for impact to local procedures.
+ COE SME for Documentation at the Westport Site.
Qualifications
+ 3+ years' experience in a similar Quality Management role
+ Proven leadership and team management experience in a Quality Team
+ A relevant tertiary qualification is desirable
+ Strong decision-making skills and the ability to work independently
+ Excellent team-building skills
+ Experience coordinating meetings with both Global and Local Teams
+ Proficient in quality management systems
+ Outstanding communication and interpersonal skills
+ Excellent IT skills
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are currently hiring a Quality Systems Manager to join our team in Westport for a 6 month fixed term contract. The Quality Systems Manger is responsible for the processing of all electronic documentation and printing of controlled documents for Batch Records for the Westport site. The DCC and Quality Batch Issuance Department must maintain compliance with local, regulatory and legislative requirements with regards to Safety, Housekeeping, GMP and support and comply with internal environmental health and safety requirements, procedures and policies. It achieves these functions by interaction with QA, EHS, Compliance and regulatory affairs to ensure all internal procedures reflect current requirements.
Responsibilities:
+ Management of the Document Control and Quality Batch Issuance Teams.
+ Management of SOP, Manufacturing and QA Type Documents onsite.
+ Hosting of Team Tier Board.
+ Priority Scheduling.
+ Collection of metrics for DCC and Quality Batch Issuance Departments.
+ Processing of team GTW records.
+ Oversight of addition of SOPs to LMS Compliance Wire.
+ Approval of DCC related SOPs and internal documentation.
+ Co-ordination of file retention activities onsite.
+ Site Representation for Global Documentation Projects.
+ Co-Ordination of Global Documentation updates for impact to local procedures.
+ COE SME for Documentation at the Westport Site.
Qualifications
+ 3+ years' experience in a similar Quality Management role
+ Proven leadership and team management experience in a Quality Team
+ A relevant tertiary qualification is desirable
+ Strong decision-making skills and the ability to work independently
+ Excellent team-building skills
+ Experience coordinating meetings with both Global and Local Teams
+ Proficient in quality management systems
+ Outstanding communication and interpersonal skills
+ Excellent IT skills
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
2
Quality Systems Engineer
Galway, Connacht
Celestica
Posted 6 days ago
Job Viewed
Job Description
Req ID: 126682 Remote Position: No Region: Europe Country: Ireland State/Province: Galway City: Galway General Overview Functional Area: Quality (QUA) Career Stream: Operations Quality (OPQ) Role: Specialist (SPE) Job Title: Specialist, Operations Quality Job Code: SPE-QUA-OPQ Job Level: Band08 Direct/Indirect Indicator: Indirect Summary We are currently recruiting for a Systems Quality Engineer as part of our team in Galway. Who we are and what we do? Celestica is an Equal Opportunities Employer. Celestica enables the world's best brands. Through our unrivalled customer-centric approach, we partner with leading companies in aerospace and defence, communications, enterprise, health-tech, industrial, capital equipment, and smart energy to deliver solutions for their most complex challenges. With talented teams across North America, Europe and Asia, we imagine, develop and deliver a better future with our customers. Celestica Galway are a leader in automated manufacturing services with proven expertise in delivering scalable manufacturing solutions throughout the product Galway supports and provides Automated Technology Solutions & Health-tech Solutions for a number of customers including the Medical Device space. Your next challenge will be. Lead process/procedure definition and maintain a continuous flow of high-quality products to our customers in a contract manufacturing environment including regulatory content for the latest and more innovative medical devices. This position will be responsible for supporting some of our product family in both the Med tech and Industrial sectors liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager. Detailed Description Your day-to-day activities will include the following. Manage performance of reports Customer liaison for quality escalations and daily quality issues ensuring measured, developed and timely responses to the customer. Support the change management process and Customer requests as appropriate. High level of competence using relevant corrective action systems (e.g., CAPA) Create concise and accurate technical reports, communicate results and manage subsequent analysis queries Continually seek to drive improvements in product and process quality. Create and evaluate metrics to drive the quality improvement processes. Own, Maintain and report timely and accurate KPI's Create, and update, Procedures and Work Instructions Manage and maintain the NCMR database and report weekly to the customer. Using appropriate statistical techniques to monitor process performance (e.g.SPC, Minitab, Ppk, Gage R & Ranalysis, sampling techniques). Provide quality engineering support to the facility, including validation and risk management and review of technical documentation (eg. FMEA's, control plans) Ability to design tests, evaluate results and recommend solutions to improve the processes associated with our manufacturing. Conditions of Employment Market-competitive total reward: Company Performance bonus program, company pension and health insurance. The opportunity to become a key member of the new product introduction team in the Health Tech Quality function driven by innovation where creativity matters. Training and development opportunities, with us the sky is the limit! The opportunity to innovate, learn, mentor others and work toward your own vision of career success A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities A sustainable culture where we provide opportunities for employees to give back to the community Knowledge/Skills/Competencies Strong knowledge of quality tools, ISO / QMS standards and processes (ISO 9001, ISO13485) Knowledge of data analysis and presentation software and its uses in generating reports, capturing data and presenting data in an understandable format. Strong knowledge of product and manufacturing processes and materials properties Knowledge and understanding of the manufacturing environment and how decisions impact customer satisfaction product quality, on-time delivery and profitability of the unit Knowledge of quality tools such as FMEA, PMP, SPC, 8D methodology, etc. Knowledge of Six sigma and Lean Kaizen. Ability to effectively communicate with a wide variety of internal and external customers to summarize complex technical issues Knowledge of Med-tech and regulatory requirements (such as FDA and MDR) is a requirement of the role with pharma & food safety systems an advantage Ability to effectively lead and manage several projects simultaneously and coordinate multiple, changing deadlines while also working effectively on their own and in a team environment. Ability to be an Internal Auditor Typical Education Bachelor's degree in related field 6 years or more experience in a manufacturing environment within a Quality function Experience in a Med-tech environment is essential Experience of 6 Sigma quality methods would be a distinct advantage. Materials engineering experience/quality materials testing knowledge is an advantage Experience of leading a team is an advantage. Notes This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time. Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them. COMPANY OVERVIEW: Celestica (NYSE, TSX: CLS) enables the world's best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development - from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers. Celestica would like to thank all applicants, however, only qualified applicants will be contacted. Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services. To Apply Please forward your CV via the APPLY Now button below.
This advertiser has chosen not to accept applicants from your region.
3
Food safety & Quality Systems Specialist
Cork, Munster
Harry Walsh Associates Ltd.
Posted 17 days ago
Job Viewed
Job Description
Food safety & Quality systems specialist required for a Global Food Manufacturer . Responsibilities: Assures preparation & attendance to the internal and external audits (such as ISO 9001, FSSC 22000, FSMA, Food Safety and Quality Industrial Audit, ) Cooperates with other departments in different audit activities (such as SMETA etc) Guarantees internal audits (planning, execution, monitoring and training of auditors) Monitors Quality KPIs (such as consumer complaints, non-conformities, glass & hard plastic checks) and collaborate with relevant stakeholders on action plans Coordinates and manages CAPA status updatesand collaborate with relevant stakeholders on implementation / follow-up Updates HACCP plans using risk analysis method, manages and coordinates the food safety team Coordinates and manages Environmental Monitoring Planand collaborate with relevant stakeholders on implementation Manage traceability in the plant and coordinates required simulation for traceability. Conducts training in Food Safety, GMP in Production, GMP for Maintenance, PRPs etc Draft Manuals & Procedures and Manages Plant Quality Documentation System Coordinates and manages Food Safety related projects Experience: BSc degree in food science, food chemistry, or a related field with at least 3 years of relevant Quality systems experience in food industry. Good knowledge of ISO 9001, FSSC 22000 requirements and familiar with the production technique and quality standards for food industry. Experience in internal auditing of Quality and Food safety management system
This advertiser has chosen not to accept applicants from your region.
4
Manager, Medical Device and Combination Product Quality Systems
Sligo, Connacht
AbbVie
Posted 7 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
5
Manager, Medical Device and Combination Product Quality Systems
Westport, Connacht
AbbVie
Posted 7 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
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6
Manager, Medical Device and Combination Product Quality Systems
Dublin, Leinster
AbbVie
Posted 7 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport, otherwise in one of our other Ireland sites.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport, otherwise in one of our other Ireland sites.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
7
Senior Quality Assurance Systems Specialist
Dublin, Leinster
Life Science Recruitment Ltd
Posted 8 days ago
Job Viewed
Job Description
Senior Quality Assurance Systems Specialist RK4434 Contract 12 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, oversight of applicable QMS systems supporting and the overall Quality Management Review process. Provide Quality direction and input at Change Control and Deviation Review Boards and assume oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. Oversee and implement Quality Agreements relating to area of responsibility. Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines associated to Quality Systems. Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or Corporate policies & procedures. Oversight and management of Quality Risk Management (QRM) Processes and for the embedding of QRM principles within the quality framework. Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, Deviation/CAPA processes and Documentation Management. Responsible for trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy. Responsible for challenging current procedures and practices, interpretation of trend data and for making any necessary revisions to quality programs to afford optimisation and further development of existing quality standards and overall compliance. In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience and knowledge. Ensuring that the self-inspection, audit and key compliance systems are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at site. Educational and Experience University degree. Engineering or Science related discipline preferred. Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Experience working in aseptic operations, protein formulation, vial and syringe filling. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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Finance Manager (Process Improvement)
Dublin, Leinster
Morgan McKinley
Posted 6 days ago
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Our finance team is currently undergoing significant transformation, moving from siloed operations to a more centralised and streamlined operating model, enhancing efficiency and consistency across the authority. Where previously we monitored from a distance the financial operations of our Service providers, we are changing strategy to be more involved at granular level of our payment operations. The consolidation into a single ERP and the integration of an advanced automated reconciliation tool will greatly improve financial controls and transparency. Role: The Finance Manager - Ticketing Technology will play a key role within the TT Finance Team, supporting daily operations, updating policies and procedures for the new finance system, managing working capital, handling reconciliations, and contributing to the delivery of financial reporting. With the Transport Technology Finance Team embarking on new schemes and projects, this role offers an exciting opportunity to help streamline processes and drive improvements. The individual will also assist in the transition from manual to systemised processes, while fostering a professional, collaborative environment within the finance team. The Finance Manager Accountant shall undertake tasks including but not limited to those listed below to the highest standards. The role will also deputise for the Finance Manager - Ticketing Operations as required: 1. Policies, Procedures and Process Improvement: 2. Assist in the review and update of Transport Technology finance Policy & Procedure Documents, using new standard templates, to reflect changes required for the new Business Central ERP Finance System and scheme changes in Leap and mTicketing (TFIGo). 3. Lead on the documentation of key controls in Transport Technology Finance. 4. Support system development and upgrades within Transport Technology from a finance perspective. 5. Assist with process improvements and the development of finance controls. 6. Contribute to the development of internal finance portals and business partnering reporting. 7. Support the implementation and enhancement of business analysis and reporting. 1. Ticketing Operations: 2. Drive process improvement and documentation 3. Assist in the review of key finance monthly controls 4. Problem solve issues as they arise liaising with internal and external stakeholders. 5. Manage the daily banking operations of the mTicketing business, ensuring all funds are processed efficiently and accurately. 6. Manage payments to Scheme Participants (Transport Operators) by preparing and executing all banking transactions efficiently. 7. Ensure that all transactions are processed promptly and accurately. 8. Support daily working capital management, ensuring liquidity and efficient cash flow management; and 9. Participate in projects aimed at improving operations, leveraging technology to automate and streamline processes. 1. Month-End Reconciliations: 2. Complete and review month-end reconciliations investigating and resolving any variances. 3. Prepare and review balance sheet and intercompany reconciliations, ensuring alignment with business units and stakeholders. 4. Contribute to the transition from manual reconciliation processes to a more systemised solution, driving efficiency and accuracy. 5. Collaborate with Finance Managers and other teams to ensure reconciliation processes are standardised and aligned across the business; and 6. Support the preparation of monthly management accounts and reporting packs, providing variance analysis and insights to support decision-making. 1. Additional Responsibilities: 2. Prepare and present monthly KPI reports to management, ensuring key financial metrics are monitored. 3. Assist in the annual budgeting and forecasting processes, providing financial analysis and reporting expertise. 4. Support interim and year-end audit processes and liaise with auditors as needed; and 5. Cultivate a positive working environment by ensuring professional and courteous interactions with all stakeholders and in particular building on business partnering activities within the Transport Technology Department. 1. Other Responsibilities: 2. Carry out other ad-hoc duties as required. The person: Key Competencies We require an individual with the below qualities and expertise; * Experience in financial management in a tightly controlled finance environment * Strong financial control experience, audit experience would be beneficial * Experience in managing managed service providers * Superior Report Writing skills * Good analytical ability, with a logical approach to problem solving and sound judgement. * Capacity to proactively and constructively contribute to team tasks. * Strong organisational and administrative skills. * A keen eye for detail and desire to probe further into data. * Deadline-orientated and an ability to stick to time constraints. * Strong MS Office skills (proficiency with MS Excel and MS PowerPoint). * Ability to communicate and interact effectively with stakeholders; and * A 'can-do' approach with the ability to organise and prioritise workloads to meet deadlines. Requirements for the Role * A proactive and driven accountant with a recognised professional qualification (e.g., ACA, ACCA, CIMA). * Strong attention to detail is essential. * Experience in drafting policies and procedures and reports. * Experience in mapping processes and * Experience on the preparation of management accounts, reconciliations and annual financial statements. * Excellent interpersonal and communication skills both written and verbal. * Business analyst skills would be beneficial * Ability to work on own initiative, as part of a team and as leader of a group; and * Experience working with multiple financial applications and systems is desirable. Benefits: Work From Home
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