LSC have a great contract opportunity for QA Engineer to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
If you have Knowledge of the regulatory and compliance requirements for medical devices and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Responsible for documenting supplier quality agreements and periodic review of supplier quality requirements.
- Responsible for quality oversight on complaint management including evaluation of product impact relating to risk.
- Support risk management activities in maintaining up to date product risk management files.
- Support quality governance activity such as Management Review trending & reporting, ensure timely entry, processing, and closure of quality records and change controls in compliance with procedures.
- Ability to support continuous improvement initiatives and work cross functionally to develop a more robust QMS.
- Ability to work cross functionally with Tech Ops, Complaints, Quality Systems (CQSC), Supplier Quality Management, Operations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of a B.Sc. or B. Eng. degree in biomedical/mechanical engineering, Medical Device Quality, Quality Assurance, or another related subject.
- Minimum of 7+ years' experience in Quality with medical device or combination products in a regulated environment.
- Risk Management Standard for Medical Devices ISO 14971 2019
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 LSC on 021-4777329 if you have any more questions about this role!