LSC have a great contract opportunity for a Quality Engineer to join a multinational medical device company based in Cork.
If you have BSc in Engineering or Science and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
- Determine the implications of validations upon, Product Quality, Patient Safety, and Data Integrity.
- Determine process inputs and factors for variation where process capability is required.
- Responsible for reviewing Installation, Operating and Performance Qualification (IQ, OQ, PQ)s.
- Responsible for conducting Test Method Validations as required
- Develop/Review pFMEA documentation to support processes as part of Validation process
- Conduct investigation, bounding, documentation, review, and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
- 2 years’ experience in a medium to high volume manufacturing environment and 1 year in a similar capacity in a regulated industry
- Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
- A thorough understanding of GMP/ISO and validation regulations.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Pawel Jurkiewicz at if you have any more questions about this opportunity!