49 Product Quality jobs in Ireland

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:

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:

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:

Our client, a leading global pharmaceutical manufacturer requires an IT Business Analyst who has lead upgrades to IT systems, specifically for Quality and Supply Chain departments in a regulated environment. Responsibilities Proven experience in managing stakeholders and demonstrates ability to navigate a complex business environment. Deep understand of the current and developing IT Arena, specifically digitisation, cloud and cyber security. Initial focus is to lead remediation & upgrade projects on legacy systems to bring in-line with current technologies. Projects will be across QA, QC, Production Quality Systems and Supply Chain functions. Other projects will cover migrations, New Technology introduction, Cyber Risks and Application risk analysis. You will work with and be supported by other teams in the organisation including high level IT Architecture Team, Cyber Security, Technical Support etc. Experience A Bachelor's Degree in Computer Science or STEM Majors (Science, Technology, Engineering and Math) or equivalent Strong relevant professional experience in working in the Pharma or IT Industry including experience in the Digital Lab domain Technical experience with Quality platforms such as, but not limited to LIMS (Lab Information Management System), Chromatography systems (Chromeleon, Empower) , Environmental Monitoring, Quality Management systems is Mandatory. Expert understanding of analysis & design and system architecture concepts. Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11. Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues. Expert understanding of the Lab business processes, drug development experience an advantage Ability to break down problems, build requirements for development tasks in an agile manner. Skills: LIMS Chromatography Systems Quality management systems CSV

**Senior Manager Quality Assurance, New Product Introduction (NPI)**
**Strategic QA leader** with a passion for people, innovation, and excellence. We're looking for someone who thrives at the intersection of **quality and transformation** , and who's ready to shape the future through enabling technology platforms and innovative supply chain solutions alongside our **AMagine partners** . A Passionate Quality Leader who will lead the execution of **quality strategies** for New Product Introductions (NPI), with a strong focus on **speed-to-market, risk mitigation** , and **compliance** .
**Position Summary**
As a global partner & leader of the Quality Assurance (QA) AMagine and NPI team, this role advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance for new product launches and in the Personalised Solutions space. This leader will influence the development and introduction of new products, processes, and technologies, with focus on process risk management including robust pFMEA to deliver highest quality products at launch.
Inspires NPI team in partnering to drive robust preventative measures and improvements of product quality and process design.
**Position Requirements**
Working within the regional NPI Quality structure, in a leadership capacity, has responsibility for quality related activities, including, but not limited to the following:
+ **Sets direction:** Drives the execution of new product development strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability.
+ **Builds organizational capability:** Promotes the optimisation of inspection strategies for launch through technology, automation, and supplier certification. Enables the development of lean inspection strategies, enabling lower inspection cost per unit.
+ **Inspires others** : Coaching and development of staff who champion quality assurance during the product development process, ensuring product launches meet or exceed established metrics.
+ **Delivers results:** Oversight and responsibility to ensure appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process.
+ Drives robust pFMEA and critical to quality attributes (CQA) identification to deliver accurate process risk identification, process characterization, process validation, process capability, robust process control and supplier capability.
+ Fosters collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with new product launch.
+ Collaborate with Regional NPI QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global NPI QA team.
+ Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful New Product Introductions that meet the NPI project goals as well as the regulatory requirements.
+ Oversight and responsibility to ensure adherence to product quality performance indicators (supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is), in conjunction with other targets per the design transfer agreement plan (DTAP). Continuously monitors to assess opportunities for improvement.
+ Ensures effective processes in selection of competent talent and supports the development of future potential experts and leaders. Ensures effective training and performance management processes are in place and executed.
+ Advocates for the design of robust inspection strategies including CQA's, CTQ's and test method validations.
+ Guides the team to onboard suppliers with demonstrated quality, process capability and validation. Ensures robust supplier pFMEA, PPAP, supplier certification and inspection methods where appropriate.
+ Influences processes towards validation versus manual verification, where possible.
+ Ensures compliance to Stryker Corporate, GQO and external regulatory requirements.
**Qualification Knowledge Skills**
+ Bachelor's Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage.
+ Minimum of 10+ years' experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
+ Minimum of 6+ years' experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team.
+ Experience in multiple areas / sites/ positions in the quality organization is advantageous.
+ Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other bodies.
+ Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.
+ Demonstrated leadership ability to develop and implement organization and functional strategy.
+ Initiates, sponsors, and implements change with a demonstrated track record.
+ Must be able to work in a team & individual environment, influencing effectively at all levels, and across all functions with ability to develop organizational relationship and build trust.
+ Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency always.
+ The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines.
#IJ
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Senior Manager Quality Assurance, New Product Introduction (NPI) Strategic QA leader with a passion for people, innovation, and excellence. We're looking for someone who thrives at the intersection of quality and transformation, and who's ready to shape the future through enabling technology platforms and innovative supply chain solutions alongside our AMagine partners. A Passionate Quality Leader who will lead the execution of quality strategies for New Product Introductions (NPI), with a strong focus on speed-to-market, risk mitigation, and compliance. Position Summary As a global partner & leader of the Quality Assurance (QA) AMagine and NPI team, this role advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance for new product launches and in the Personalised Solutions space. This leader will influence the development and introduction of new products, processes, and technologies, with focus on process risk management including robust pFMEA to deliver highest quality products at launch. Inspires NPI team in partnering to drive robust preventative measures and improvements of product quality and process design. Position Requirements Working within the regional NPI Quality structure, in a leadership capacity, has responsibility for quality related activities, including, but not limited to the following: Sets direction: Drives the execution of new product development strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability. Builds organizational capability: Promotes the optimisation of inspection strategies for launch through technology, automation, and supplier certification. Enables the development of lean inspection strategies, enabling lower inspection cost per unit. Inspires others: Coaching and development of staff who champion quality assurance during the product development process, ensuring product launches meet or exceed established metrics. Delivers results: Oversight and responsibility to ensure appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process. Drives robust pFMEA and critical to quality attributes (CQA) identification to deliver accurate process risk identification, process characterization, process validation, process capability, robust process control and supplier capability. Fosters collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with new product launch. Collaborate with Regional NPI QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global NPI QA team. Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful New Product Introductions that meet the NPI project goals as well as the regulatory requirements. Oversight and responsibility to ensure adherence to product quality performance indicators (supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is), in conjunction with other targets per the design transfer agreement plan (DTAP). Continuously monitors to assess opportunities for improvement. Ensures effective processes in selection of competent talent and supports the development of future potential experts and leaders. Ensures effective training and performance management processes are in place and executed. Advocates for the design of robust inspection strategies including CQA's, CTQ's and test method validations. Guides the team to onboard suppliers with demonstrated quality, process capability and validation. Ensures robust supplier pFMEA, PPAP, supplier certification and inspection methods where appropriate. Influences processes towards validation versus manual verification, where possible. Ensures compliance to Stryker Corporate, GQO and external regulatory requirements. Qualification Knowledge Skills Bachelor's Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage. Minimum of 10+ years' experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment. Minimum of 6+ years' experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team. Experience in multiple areas / sites/ positions in the quality organization is advantageous. Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other bodies. Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools. Demonstrated leadership ability to develop and implement organization and functional strategy. Initiates, sponsors, and implements change with a demonstrated track record. Must be able to work in a team & individual environment, influencing effectively at all levels, and across all functions with ability to develop organizational relationship and build trust. Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency always. The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines. #IJ To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

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.
**Knowledge / Skills & Experience**
**Essential:**
+ 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 missesimmediately 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.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( 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._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Job Description Homewares Quality, Product and Assurance Manager Dunnes Stores is Ireland's leading retailer positioned at the cutting edge of food, fashion and home retailing. With a strong focus on quality and safety we are dedicated to maintaining our position as a market leader. As we continue to grow, we are looking for a passionate and experienced Homewares Quality, Product and Assurance Manager to ensure the highest standards of quality and safety are achieved across all product categories. This role will work with the buying teams, designers and suppliers on technical details to ensure new products and packaging are commercially viable, and compliant with current legislation and performance requirements. Attend and contribute to pre-production meetings with Suppliers, buying teams and design teams to ensure selected products are suitable for bulk production, performance, presentation, and exceed customer expectations. This role will be responsible for all aspects of home product testing on the portal including failed test results. They will take a hands-on role with suppliers regarding the sample sealing process, risk assessments, critical paths, checking strike off/bulk fabrics, packaging proofs, inspection reports and gold seal samples to ensure compliance to all requirements. Communicating appropriate approvals and rejections back to the supplier/ internal team will be a task often completed. The role will provide regular updates to internal stakeholders on sample submissions, customer complaints and competitor product comparison as well as establish and maintain the homewares supplier manual, to ensure the brand performance standards are up to date, consistent, and comprehensive in line with current legislation and industry norms. They will develop supplier relationships to ensure product consistency across the supply base for quality, finish, packaging and safety. This role will hold suppliers accountable for performance on sampling, testing and inspection dates including 'right first time' sample submission within agreed deadlines and record results. They need to be flexible and capable of adjusting daily work priorities to meet business needs, they must be able to deal quickly and effectively with daily email communications to and from suppliers, customer services and internal teams. The role will keep the business informed of all relevant safety and quality issues. When required they will visit the warehouse to check stock if quality issues are reported. When buyers generate a weekly list of new styles arriving in stores this role will carry out inspection and report findings. Skills and Experience Experience in a similar role. Enthusiastic team player, with a proactive approach, good communication skills and a collaborative attitude. Organised, and capable of prioritising multiple tasks. Exceptional attention to detail. Confident to make decisions and take responsibilities, yet unafraid to seek advice. An inquisitive mind set, with a keen interest in developing themselves, and ambition to grow their insight and knowledge within the industry. A desire for continuous product excellence, and improvements. A strong communicator with ability to present confidently via email, audio conferencing and face to face with internal stakeholders, suppliers and customers. A positive approach and mentality to product data harvesting, document population, maintenance and management. Ability to work effectively in a high volume, fast paced environment. 3 or more years' experience of working in a related role. Responsible to for ensuring compliance with the below in REACH Directive EC 1907/2006 Toy Safety Directive 2009/48/EC Textile testing and performance standards Food contact materials regulation (EC) No1935/2004 Unique Formula Identifier (UFI) PPE regulations Awareness of new regulations e.g. Glitter EUTR / EUDR Regulations Benefits: Competitive salary Comprehensive benefits package including employee discounts Opportunities for professional development and career growth A dynamic and inclusive work environment focused on sustainability and innovation Dunnes Stores is an Equal Opportunities Employer

Job title:Quality Assurance Associate Location:Bishopstown, Cork. Benefits:Excellent salary, 10% bonus, hybrid working, healthcare and pension. Company: My client, spun out from Munster Technological University (formerly Cork Institute of Technology) in 2015, develops innovative ENT (Ear, Nose, and Throat) medical devices that simplify surgical procedures by enabling treatments to be conducted safely outside the operating roomtypically with just topical anesthesia. Role: You will be responsible for assisting in the maintenance of the Quality Management System (QMS), assist with the management of internal processes and external vendors to ensure product quality. This involves managing supplier relationships, participating in audits, resolving quality issues, driving continuous improvement initiatives and collaborate with various teams to maintain quality across the supply chain. The person in this position must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. Job Requirements: Maintaining the effectiveness of the QMS and making continuous improvements to it. Managing day-to-day QA activities including frequent interface with contract manufacturers, QA consultants and testing contractors as well as handling multiple projects related to product and compliance enhancements. Responsible for assisting in notified body audits and internal audits. Maintain and coordinate quality system schedules, including: Supplier and internal audits; management review and documentation updates. Support the wider team to ensure product manufacture and testing meets the requirements. Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting audits to ensure compliance with quality standards. Investigating, analysing, and resolving any product quality problems, including root cause analysis and implementing corrective and preventive actions. Ensuring that incoming materials meet the required specifications and working with the engineering team to address any quality concerns. Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to: coordinating investigations between complainants and contract manufacturing sites follow up on corrective actions, when required Support with Significant Changes and Notified Body interactions. Carry out other quality related duties as required, inclusive of updates to procedures, forms, processes and periodic reviews. Education Bachelors degree in engineering or science. Quality certification in ISO 13485 a must. A minimum of 4 years of experience in a medical device QA position(s) role within a medical device organisation. Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR and 21 CFR Part 820. Desirable to have lead auditor certification and/or Regulatory certifications. Proven track record with the ability to successfully manage projects to deadlines. Good Documentation Practice experience. Report & Technical Writing experience. Project Management experience. Strong ability to manage critical projects as part of an interdisciplinary team. Excellent problem solving and communication skills. Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on OR Benefits: Healthcare + Annual Bonus + Pension