LSC have a great contract opportunity for a Quality Engineer to join a multinational medical device company based in Cork.
If you have experience working in both an FDA and European regulatory environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Conduct benchmarking to develop more effective methods for improving quality
- Review/analyze whether current product and processes (including actions or
decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.
- Supports activities related to the Material Review Board.
- Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans
- Develop, interpret and implement appropriate process monitoring and control
methods consistent with the level of process/product risk.
- Ensures effective quality strategies are created for the validation of test methods,
process and design.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A minimum of a Bachelor's Degree, preferably in Engineering or related technical
field. Generally, requires 2-4 years related experience.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards)
- This position will require relevant experience working in
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 Gráinne Hodnett if you have any more questions about this opportunity!