Senior Quality Engineer - Risk Management
CK Group are recruiting for a Senior Quality Engineer to join rapidly growing research and development company at their site based in Stirling on a permanent basis.
The Company: Our client is offering an opportunity to be involved in transformingIn Vitroccess of the business.
Location: This role is located at their state of the art facility based in Stirling. There are good transport links and the site is easily accessible from the M9. Stirling is a desirable place to live and work andis easily commutable from Glasgow, Edinburgh or Dundee.
Senior Quality Engineer Role: The successful candidate shall be responsible for the quality and regulatory activities associated with IVD assays and Quality Controls through the design anddevelopment, verification and validation, transfer to manufacturing and release and post market phases.
Your main duties will be to:
- Ensure that all Risk Management Procedures are conducted in compliance with ISO 14971 Medical devices. Application of risk management to medical devices.
- Ensure that all Risk Management activities are conducted appropriately to fulfil the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions.
- Ensure that a robust process is in place so that all Post Market surveillance data is integrated back into the Risk Management activities.
- Support the transfer of product from R&D to manufacture.
- Support the creation of the technical files for CE marking.
Your Background: The ideal candidate for this role will have:
- Experience of Risk Management in an IVD or Medical Device environment.
- Experience of working in an IVD or medical device environment with a strong quality and regulatory focus and experience through development and verification and validation activities.
- A scientific background.
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.Apply: For more information or to apply for this Senior Quality Engineer position, please contact Georgia Bernard on 0191 384 8906 or email email@example.com, quoting job ref 49927.
It is essential that applicants hold entitlement to work inthe UK.