296 Product Quality jobs in Ireland
Product Quality Engineer
Posted today
Job Viewed
Job Description
The Role Profile
The Product Quality Engineer will serve as a critical interface between the Quality and R&D teams, ensuring that product design—both hardware and software—meets quality standards from concept through launch, while also providing long-term sustaining support. This role requires strong technical acumen, hands-on engagement with product development, and a proactive approach to risk mitigation and design assurance.
The role also involves supporting Process Quality, Production, Test Engineering, and R&D teams in resolving product-related issues, particularly those involving hardware and firmware functionality and design integrity.
Key Responsibilities:
- Work closely with R&D to assess and influence product designs for quality, reliability, and regulatory compliance.
- Evaluate schematics, PCB layouts, and hardware specifications to identify potential design-related quality risks and ensure robust engineering standards are met.
- Lead design risk assessments (e.g., DFMEA) and support root cause analysis for design-related issues.
- Support NPI validation and verification strategies.
- Support Purchasing team and R&D teams with New Vendor and part approvals processes with a focus on ensuring quality is maintained.
- Statistical analysis and reporting of parametric test data.
- Support software and hardware testing from a quality perspective.
- Provide technical support to Production, Test departments and Process Quality Engineers in resolving product-related issues, ensuring effective communication between R&D and operations.
- Ensure traceability and compliance with regulatory and internal standards.
- Drive continuous improvement in design processes and quality metrics.
- Act as a technical quality representative in design reviews and product development meetings.
- Support audits and regulatory inspections related to design controls.
Qualifications & Experience:
- Bachelor's degree in engineering (Electronic, Electrical, Software, or related).
- 5+ years in a Quality or R&D role within a regulated industry (e.g., medical devices, aerospace, automotive, life safety).
- Strong understanding of product development, lifecycle and design controls.
- Experience with hardware/software integration and testing.
- Familiarity with ISO 9001, or similar standards.
Skills & Competencies:
- Ability to read and understand electronic schematics and circuit designs.
- Experience with FMEA, risk management, and root cause analysis tools.
- Knowledge of embedded systems, firmware, or software development.
- Strong communication and cross-functional collaboration skills.
- Ability to interpret technical drawings, specifications, and test data.
Product Quality Manager
Posted today
Job Viewed
Job Description
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
The Product Quality Manager will act as the manager of the product quality solutions & containers team. You will ensure global quality of the solutions & containers products.
Essential Duties and Responsibilities:
- Ensure Quality System processes are correctly implemented to meet requirements for new product development and lifecycle management for medical devices and drug products.
- Provide and lead the core teams to achieve Quality deliverables that are required to support regulatory submissions of new products to Notified Bodies, MoH, and the FDA.
- Provide technical and leadership support for the execution/implementation of the assigned tasks related to New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects.
- Ensure sites and team audit readiness for internal and external audits.
- Lead and approve NCR/CAPA projects.
- Accountable for timely and accurate reporting of PQDR (Product Quality Data Reviews) data to ensure that post-production information is used as input for proactive improvement of products' performances.
- Drive implementation of best practices in Product Development and lifecycle management processes, including Change Management and Risk Management.
- Provide guidance on maintenance of product Design History Files and other Management Files according to relevant Quality System and other Regulatory requirements for therapeutics and medical devices.
- Interface with Research & Development, Regulatory Affairs, Medical, Manufacturing, and other disciplines to represent QA in project teams, with the objective to assure that the project quality objectives are met.
- Drive and champion the awareness and implementation of Vantive Quality policy and objectives.
- Manage Product Quality resources and budget for the solutions and containers team, also responsible for the team's development and training.
Knowledge and Skills:
- Knowledge of FDA (21 CFR Part 210, 211 & 820), ICH, and EMEA regulations (EU, GMP Part I & II) and ISO 13485 and 14971, MDR.
- Experience in leading project teams and Quality Initiatives (processes, systems, improvements) in an international environment.
- Strong communication and organizational skills.
- Compliance knowledge in the areas of pharmaceutical product and medical devices development, change control, CAPA.
- Ability to articulate customer needs and incorporate them into work.
- Ability to work with minimal supervision and to make decisions even if provided with limited information.
- Strong analytical and problem-solving skills, preferably utilizing DMAIC tools; Six Sigma Engineering.
- General understanding of applied Statistical Methodologies.
Education and/or Experience:
- University degree in Pharmacy, Engineering, Chemistry, or Biochemistry.
- Minimum of five years' experience in the pharmaceutical or medical device environment.
What Vantive can offer to you:
- A permanent contract with a stable and secure work environment
- A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme
- A collaborative and dynamic work environment
- Access to state-of-the-art equipment and technology
- Recognition and reward for outstanding performance
Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link
Recruitment Fraud Notice
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Product Quality Engineer
Posted today
Job Viewed
Job Description
We are seeking an experienced
Product Quality Engineer
to join our client's growing team. This is a pivotal role working across
R&D, Quality, Production, and Test Engineering
, ensuring that both hardware and software product designs meet the highest standards of quality, reliability, and compliance.
The ideal candidate will have strong technical expertise, hands-on experience with product development, and the ability to influence design processes from concept through to launch and beyond.
Responsibilities
- Collaborate with R&D teams to assess and influence product designs for quality, reliability, and compliance.
- Review schematics, PCB layouts, and hardware specifications to identify potential design risks.
- Lead design risk assessments (DFMEA) and support root cause analysis activities.
- Support validation and verification for new product introductions.
- Partner with Purchasing and R&D teams to qualify new vendors and parts.
- Perform statistical analysis and reporting of test data.
- Support hardware and software testing from a quality perspective.
- Provide technical support to Production, Test, and Process Quality teams to resolve product-related issues.
- Act as a technical quality representative in design reviews and development meetings.
- Support audits and inspections related to design controls.
- Drive continuous improvement in design processes and quality metrics.
Requirements:
- Bachelor's degree in
Electronic, Electrical, Software Engineering, or related field
. - 5+ years' experience
in a Quality or R&D role within a regulated industry (medical devices, aerospace, automotive, or life safety). - Strong understanding of product development lifecycle and design controls.
- Experience with hardware/software integration and testing.
- Familiarity with ISO 9001 or similar quality management systems.
- Ability to interpret electronic schematics, circuit designs, and technical specifications.
- Skilled in FMEA, risk management, and root cause analysis.
- Knowledge of embedded systems, firmware, or software development.
- Strong communication and cross-functional collaboration skills.
For a confidential conversation about the role contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
Product Quality Manager, Programmatic
Posted today
Job Viewed
Job Description
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
The
Product Quality Manager
will act as the manager of the product quality solutions & containers team. You will ensure global quality of the solutions & containers products.
Essential Duties And Responsibilities
- Ensure Quality System processes are correctly implemented to meet requirements for new product development and lifecycle management for medical devices and drug products.
- Provide and lead the core teams to achieve Quality deliverables that are required to support regulatory submissions of new products to Notified Bodies, MoH, and the FDA.
- Provide technical and leadership support for the execution/implementation of the assigned tasks related to New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects.
- Ensure sites and team audit readiness for internal and external audits.
- Lead and approve NCR/CAPA projects.
- Accountable for timely and accurate reporting of PQDR (Product Quality Data Reviews) data to ensure that post-production information is used as input for proactive improvement of products' performances.
- Drive implementation of best practices in Product Development and lifecycle management processes, including Change Management and Risk Management.
- Provide guidance on maintenance of product Design History Files and other Management Files according to relevant Quality System and other Regulatory requirements for therapeutics and medical devices.
- Interface with Research & Development, Regulatory Affairs, Medical, Manufacturing, and other disciplines to represent QA in project teams, with the objective to assure that the project quality objectives are met.
- Drive and champion the awareness and implementation of Vantive Quality policy and objectives.
- Manage Product Quality resources and budget for the solutions and containers team, also responsible for the team's development and training.
Knowledge And Skills
- Knowledge of FDA (21 CFR Part 210, 211 & 820), ICH, and EMEA regulations (EU, GMP Part I & II) and ISO 13485 and 14971, MDR.
- Experience in leading project teams and Quality Initiatives (processes, systems, improvements) in an international environment.
- Strong communication and organizational skills.
- Compliance knowledge in the areas of pharmaceutical product and medical devices development, change control, CAPA.
- Ability to articulate customer needs and incorporate them into work.
- Ability to work with minimal supervision and to make decisions even if provided with limited information.
- Strong analytical and problem-solving skills, preferably utilizing DMAIC tools; Six Sigma Engineering.
- General understanding of applied Statistical Methodologies.
Education And/or Experience
- University degree in Pharmacy, Engineering, Chemistry, or Biochemistry.
- Minimum of five years' experience in the pharmaceutical or medical device environment.
What Vantive Can Offer To You
- A permanent contract with a stable and secure work environment
- A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme
- A collaborative and dynamic work environment
- Access to state-of-the-art equipment and technology
- Recognition and reward for outstanding performance
Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link
Recruitment Fraud Notice
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Trainee Product Quality Technologist Placement Student
Posted today
Job Viewed
Job Description
Trainee Product Technologist — Placement Student
Because you'll make the difference
Ready to own your career in an ever-growing fashion hub? Then take on a Primark placement starting in Summer 2026. This is your chance to grab valuable experience in a global company that truly feels like a family. You'll have real projects with real autonomy. You'll get to know incredible experts who make our fashion a reality. And you'll gain off-the-scale exposure, making a huge impact for our customers and your future. Want it? Then own it on our undergraduate placement programme.
Because you matter
People are at the heart of what we do, so it's essential that we provide you with the right environment to perform at your very best. We offer benefits that put you first:
- Pay rate: Generous EUR 30,000 salary
- Development: A 12 month development programme which kicks off with our Freshers Week
- Balance: Our 'Your Day, Your Way' approach means you can finish up at 2pm every Friday if you've done your 37.5 hours that week
- Discounts: Use your in-store colleague discount across our fabulous range
- Support: Explore our well-being initiatives and Employee Assistance Programme, Let's Talk. As well as mentorship to get the most out of your year
- Holiday: Enjoy 27 days holiday on top of the Bank Holidays
And if you need to relocate to Dublin for the role:
- We'll support you with: flights at the start and end of your placement, an additional gross relocation allowance of EUR 1000 in your first month pay to help get you settled in, a bundle of homeware so you don't have to pack your duvet and pillows and a travel allowance to support with your travel over the holiday season. We'll also support you opening a bank account and registering for tax and social security in Ireland.
- Not sure where to live? Primark currently partner with Highfield House, student accommodation. You will have the option to stay at Highfield House and if you do, Primark will generously contribute towards 25% of your total annual rent and cover your deposit
About you
If you're an undergraduate looking for a 12 month placement before you head back to university for your final year, we'd love to hear from you. If you're in your last year at university or have already graduated, head back to the careers website to find other roles across the business.
About the placement
You don't watch from the sidelines around here — you get stuck in. Through hands-on experience and responsibility from the get-go, you'll gain a vast insight into how our business works and contribute to it from day one. Inspiring, supportive colleagues will make you feel welcome and valued. And we'll also help you to develop your skill set and grow your potential through supported learning with on-the-job training, masterclasses, and an assigned buddy.
What you'll need
Collaboration skills are first and foremost. You'll also be a multitasker who can plan and prioritise — especially where your own work is concerned — and you'll bring us integrity, initiative, and sound judgement. If you have all that and more, the Primark placement in Quality is the perfect fit for you.
What you'll do
Imagine the number of product lines in our stores—from fashion to footwear, accessories to homeware, and even beauty. Now imagine the scale of the operation it takes to ensure every single item meets our exacting standards. This is where you'll shine. Life in the Quality team at Primark is fast-paced and exciting. Working in partnership alongside Buying, Merchandising & Design teams across a wide range of categories—including Apparel, Footwear, Accessories, Homeware, and Beauty—as well as our suppliers, you'll help ensure each product is safe, legal, and exceeds customer expectations.
Drawing on your existing technical knowledge, you'll be involved in both product and process helping identify and investigate any issues. You'll engage with suppliers and support Product Technologists in delivering training, giving you an incredible grounding in every aspect of product quality across multiple categories.
Product Technologists deliver training. So you'll get an amazing grounding in every aspect of product quality.
Why should you apply?
In Primark, we've always said everyone's invited and we're committed to making everyone feel safe and comfortable to be themselves. We believe that a diverse, inclusive, and accessible environment elevates us all, and enables creative ideas and collaboration to flourish. Because when we work together, we can accomplish so much more.
And yes, this place moves fast, and it's growing even faster but we're committed to providing the best, and most socially and environmentally ethical fashion that's affordable for everyone. Primark Cares is our commitment to reducing fashion waste, halving our carbon footprint, and improving the lives of the people who make our products.
This placement has real impact, you could even see the results of your work, out on the shop floor Make your CV look amazing and if you wow us, there could be a permanent job up for grabs when you graduate.
Isn't it time you put theory into practice? We think so. Apply now for a Primark placement and start owning your journey.
Closing date: Friday 7th November 2025. We reserve the right to close the application window early should we receive sufficient applications
Our fashion isn't one-size-fits-all and neither is our culture. Primark promotes equal employment opportunity, we strive to create an inclusive workplace where people can be themselves, access opportunities and thrive together.
REQ ID: JR-1573
Manager, Medical Device and Combination Product Quality Systems
Posted 19 days ago
Job Viewed
Job 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:
Manager, Medical Device and Combination Product Quality Systems
Posted 19 days ago
Job Viewed
Job 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:
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Manager, Medical Device and Combination Product Quality Systems
Posted 19 days ago
Job Viewed
Job 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:
Product Complaints Quality Manager
Posted today
Job Viewed
Job Description
Product Complaints Quality Manager, 12 months contract
Company Name:
Vertex Pharmaceuticals
Location:
Hybrid, 3 days on site in Dublin, Ireland
Department:
Operational Area Quality
Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
General Summary:
The Quality Product Complaints Manager is responsible for providing quality oversight of the Product Complaint Quality System and Global Recall and Defect Notification Systems.
This role will support quality activities associated within the CMC Compliance team and will partner with various internal and external cross-functional teams including Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations and external Call Centers.
Key Duties and Responsibilities:
- Support activities associated with the product complaint process, including reconciliation, training, complaint sample management, triage, trending, SOP management, etc.
- Process incoming clinical and commercial product complaints, including intake, initial evaluation and triage.
- Conduct product complaint investigations and author investigation reports.
- Coordinate with CMOs as needed for external investigations.
- Perform Quality review of complaint investigations owned/authored by other members of the team.
- Escalate critical issues to senior management.
- Oversees all activities associated with the global recall and defect notification processes, including mock recalls, SOP management, evaluation of regulatory intelligence and health of the systems.
- Leads product complaint investigations, coordinates with CMOs for external investigations, performs Root Cause Analysis, identifies Corrective Actions and escalates critical issues to senior management.
- Develops quarterly product complaint trend reports, initiates trend investigations and evaluates metrics/KPIs to assess quality impact and adverse trends.
- Coordinates activities associated with Counterfeit/Suspect product investigations and evaluates third-party investigation reports for potential threats / required escalation.
- Contributes to quarterly Quality Management Review (QMR) meetings for Product Complaints.
- Supports global regulatory inspections and inspection readiness activities
Knowledge and Skills:
- Strong understanding of industry standards and best practices.
- Proven ability to collaborate with cross-functional teams.
- Proven ability to manage projects of significant scope and complexity, while meeting deliverables and timelines.
- Strong strategic, critical and analytical thinking skills.
- Strong technical writing, presentation and communication skills.
- Experience in Medical Devices and Combination Products an advantage
- Bachelor's degree in a scientific or allied health field.
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.
Quality Product Lead
Posted today
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are now looking for a
Quality Product Lead
(Permanent role) to join our team in Stamullen, County Meath.
Summary Of Role
Working within the Quality function for PCI Pharma Services (Ireland Sites) Quality Product(s) Lead will be primarily responsible for managing the quality element of New Product Introduction (NPI) and large-scale programmes relating to one Client consisting of one or more projects, each with varying complexity or multiple products within the NPI portfolio. A sound collaborator and natural leader, the Quality Product(s) Lead will display interpersonal and communication skills that build the strongest of relationships at site and customer levels. Whilst agile and customer focused, they will be a proven talent for identifying the quality needs of the project and ensuring regulatory compliance through the project/programme lifecycle.
Quality Product(s) Lead will have a proven track record in the ability to communicate and escalate effectively, be strong in team management and possess excellent coordination skills.
Key Responsibilities
- Ensure compliance with cGMP, corporate standards/PCI Quality System (PQS), site policies/procedures, regulatory requirements, and industry standards.
- Partner closely with customers and stakeholders to understand and deliver on all records within timelines and escalate when necessary.
- Participate in cross functional teams as required to provide consultative support on quality related issues and documentation management.
- Ensure that operational instructional documentation are up to date, compliant, and supports efficient production.
- Main point of Contact for all Quality escalations from Customers.
- To ensure that products/devices are packaged and controlled to meet the requisite safety and quality and GMP standards.
- Communicate regularly and effectively. Work cross functionally to ensure communication within the business is always up-to-date and utilises all available channels.
- Work closely with the Programme Manager and cross functional teams to define the programme strategy, scope and objectives.
- Working with the programme and project managers manage project timelines to ensure Quality elements of projects are delivered on time and critical paths are identified and monitored throughout their lifecycle.
- Promote engagement at all levels and stages of the programme. Encourage individuals to contribute to the success of each project and illustrate benefits brought about.
- Manage risks within the programme. Ensure risks are identified, evaluated, and controlled through the programme lifecycle.
- Follow and comply with the NPI process as per company procedures and policies.
- Display strong leadership to the various project teams from concept to handover. Lead by example in day-to-day project and team management.
- Manage change at varying levels ensuring site procedures are followed and change controls are raised at the appropriate time with the relevant approvers engaged from the outset.
- Create and sustain a working environment that promotes the PCI Values and Behaviours.
- To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
- Work with Customer to define KPI's and lead reporting of KPI's to Site and Customer Teams.
- Quality Product(s) Lead is responsible for adhering to the company's SOPs, Health & Safety, cGMP and other regulatory guidelines themselves and for team members and contractors under their control.
- Quality Product(s) Lead is responsible for the quality element of all new products/devices and their associated project phases.
- It is a requirement of this role that on occasion the individual will be required to travel on company business. This may be vendor/supplier or customer based.
Essential
Knowledge / Skills & Experience
- To have demonstrable experience within New Product Introduction (NPI) and Quality governance of same.
- To have experience of medical device assembly.
- Experience of quality critical activities within the pharmaceutical industry.
- Sound working knowledge of cGMP.
- Experience of working directly with customers as the single point of contact.
- Experience of working at management level within a similar environment an advantage.
- Experience of managing a technical/quality team.
- Strong insight into the pharmaceutical customer requirements relating to speed to market, NPI and service.
- Industry knowledge of the requirements of EU GMP and ISO requirements for Medical Devices.
- 5 years' experience working in Quality pharmaceutical or medical device role.
- Educated to EQF (European Qualifications Framework) level 6 in a Technical, Engineering or a Science subject.
- Master's degree (or higher) in a Technical, Engineering or a Science subject.
- Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
- Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
- Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Desirable
- 3 years experience working in Pharmaceutical packaging organisation or similar in medical device organisation.
- Experience in a GMP or Regulated Environment.
- Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
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Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.