Quality Assurance Manager Role Dublin

Product Quality Engineer

  • Posted Oct 24, 2022
  • Dublin
  • Contract
  • BBBH25895

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!


  • 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.


  • 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!

This could be the perfect project for you! Apply online and we’ll be in contact shortly


No jobs to suit your skill set?

Upload your CV and we’ll get in contact when we have an opportunity that matches your profile!


The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

Apply for this Job

Please enter your full name.

Enter a valid email address.

Please enter your phone number (including country and area codes if outside Ireland)

Upload your CV to accompany your application for this job.

Fields marked with * are required.