5 Quality Assurance jobs in Limerick

**18 Month FTC**
**Role: Supplier Quality Engineer (SQE)**
**Location: Hybrid**
Key Responsibilities:
+ Lead supplier engagement related to barcode readiness, including kickoff meetings and implementation tracking.
+ Review and approve supplier PPAPs, barcode validation evidence, and change notifications.
+ Ensure supplier marking systems meet MDR durability and traceability criteria.
+ Coordinate resolution of NCs, change control, and inventory disposition workflows.
+ Collaborate closely with ME/QE teams to ensure supplier deliverables align with internal barcode standards and milestones.
+ Maintain supplier audit trail and risk-based documentation for MDR compliance.
Collaborates With:
+ Manufacturing Engineering (ME) - to confirm technical specs and equipment/process readiness at suppliers
+ Quality Engineering (QE) - for PPAP/FAI review, risk assessments, and issue escalation
+ Regulatory Affairs - for MDR-related documentation checks and supplier traceability
+ Supply Chain / Planning - for coordination on supplier schedules, PO releases, and material disposition
+ Operations / Receiving Inspection - to confirm readiness to inspect and verify barcode compliance at incoming
+ Project Management (PMO) - to align timelines, flag risks, and manage cross-functional handoffs
+ IT / Supplier Portals - where applicable, for document submission or traceability in supplier systems
+ Divisional SQ / Base Business Teams - for supplier escalation paths, audit preparation, and governance reviews
Required Skills & Tools:
+ Systems: OnePLM, Trackwise, SLMS, GIM
+ Process: PPAP, supplier readiness, NC/CAPA, barcode traceability, supplier audit response
+ Standards: EU MDR, ISO 13485, UDI supplier integration
+ Competencies: Self-directed, supplier-savvy, able to manage external/internal alignment, fast-paced readiness executor
Preferred Experience:
+ MDR/UDI supplier implementation projects
+ Interaction with base business and divisional purchasing/QA
+ Barcode equipment readiness and supplier audits
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.

Overview The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, Design and Process FMEA, risk assessment and associated Quality System Documentation. Reporting to: Team Lead, Quality Engineering Department: Quality Engineering Responsibilities Department: Quality Engineering Understand and review Validation documentation, Change Requests, Design and Process FMEA's, Test Summaries, Software Validation, Microbiological assessments and Critical System Work Orders. Provide Quality Engineering support to the Research and Development and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Verification/Design Validation, Design and Process FMEA, Process Validation and Test Summaries. Support the Supplier Appraisal and Approval processes. Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control. Provide input and support to the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process. Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes Conducting, documenting and reviewing complaint investigations. Risk assessment of customer complaints, Non-conformance and CAPA's. Provide quality engineering support to the Cook Medical Europe quality system. Initiate, manage and execute projects for continuous improvement within the department. Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner. Delegate to the Senior Quality Engineer/ Quality Engineering Team Lead. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Department: Quality Engineering Third Level qualification in Science, Engineering or a relevant technical discipline. Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage. Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry. Proven knowledge and experience of all aspects of Validation including Design, Process Validation and Software Validation. Good working knowledge of statistics. Experience in combination devices would be an advantage. Strong interpersonal skill with the ability to communicate effectively at all organisational levels. The ability to challenge thinking/opinion/actions in light of ensuring Cook Medical Quality Systems and Processes are adhered to. High attention to detail in all aspects of the role. Excellent organisational skills. Proven problem-solving skills. High self motivation. Good working knowledge of Microsoft Office. Willingness and availability to travel on company business. 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 Continue to Application or Login/Register to apply button below.

Within this role you will be responsible for the oversight of Quality Control support operations. As a Manager within Quality Control a typical day might include, but is not limited to, the following: Maintaining oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning) Providing direction to Managers and staff that support the equipment Ensuring equipment qualification and maintenance programs are aligned with regulatory agencies requirements, qualified and available for QC laboratory usage Interacting with QC partner groups to establish internal requirements for equipment Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups Managing oversight of the preventive and corrective maintenance monitoring program Managing oversight of the QC external laboratories activities and performance monitoring of external testing laboratories Supervising the issuance and approval of Quality agreements and SLAs with the contract labs Verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization Identifying and calling out issues at contract laboratories to QC leadership Sourcing, co-ordinating and project management of GMP activities relating to new contract lab introduction Travel may be required in support of external contract laboratory testing activities Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations Responsibility for equipment automation and associated projects This role might be for you if you: Possess strong communication and interpersonal skills Demonstrate logical troubleshooting and problem-solving skills Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms Have the ability to communicate effectively with multiple partners Enjoy working in a fast-paced environment Demonstrate a collaborative and team-orientated approach To be considered for this opportunity you should have a BA/BS in chemistry, biology or related field with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience. #JOBSIEPR Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Within this role you will be responsible for the oversight of Quality Control support operations. As a Manager within Quality Control a typical day might include, but is not limited to, the following: Maintaining oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning) Providing direction to Managers and staff that support the equipment Ensuring equipment qualification and maintenance programs are aligned with regulatory agencies requirements, qualified and available for QC laboratory usage Interacting with QC partner groups to establish internal requirements for equipment Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups Managing oversight of the preventive and corrective maintenance monitoring program Managing oversight of the QC external laboratories activities and performance monitoring of external testing laboratories Supervising the issuance and approval of Quality agreements and SLAs with the contract labs Verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization Identifying and calling out issues at contract laboratories to QC leadership Sourcing, co-ordinating and project management of GMP activities relating to new contract lab introduction Travel may be required in support of external contract laboratory testing activities Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations Responsibility for equipment automation and associated projects This role might be for you if you: Possess strong communication and interpersonal skills Demonstrate logical troubleshooting and problem-solving skills Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms Have the ability to communicate effectively with multiple partners Enjoy working in a fast-paced environment Demonstrate a collaborative and team-orientated approach To be considered for this opportunity you should have a BA/BS in chemistry, biology or related field with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.