LSC have a great contract opportunity for Product Quality 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 minimum of a B.Sc. or B. Eng. degree in biomedical / mechanical engineering, Medical Device Quality, Quality Assurance, or other related subject and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Responsible for compliance and ensuring combination product lifecycle management activities align with regulations and regulatory inspections such as Notified Body and Health Authority Inspections.
- Responsible for quality oversight, participation and guidance for the review and approval of design changes.
- Partner with Alexion cross functional teams in the evaluation of supplier requests for device and combination products e.g., design changes, supplier quality governance and quality agreements.
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of 3+ years' experience in Quality with medical device or combination products in a regulated environment.
- Knowledge of the regulatory and compliance requirements for medical devices and/or combination products (e.g., FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and EU MDR Regulation (2017/745).
- 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 Siobhan Cummins at LSC on 021-4777329 if you have any more questions about this role!