LSC have a great contract opportunity for a Quality Engineer to join a multinational medical device company based in Cork.
If you have a BSc in Engineering or Science with 2 years’ experience in a medium to high volume manufacturing environment and 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO) and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Team member representing the Quality function supporting projects in Materials Development with a focus on metals forming processes.
o Support Quality and Validation activities for product transfers and new product introductions.
o Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
o Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
o Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).
o Determine process inputs and factors for variation where process capability is required.
o Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o BSc in Engineering or Science with 2 years’ experience in a medium to high volume manufacturing environment
o 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
o 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.
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!
To apply, submit your CV via this advert or contact Martin Taggart at LSC on 021-4777329 if you have anymore questions about this Quality Engineer opportunity!