Senior Quality Engineer - Risk Management
Stem have a fantastic opportunity for an experienced Senior Quality Engineer with strong risk management experience. Reporting to the Development Quality Engineer Manager, the successful candidate shall be responsible for the quality and regulatory activities associated with IVD assays and Quality Controls through the design and development, verification and validation, transfer to manufacturing and release and post market phases.
Some of the responsibilities include;
- Ensuring that all Risk Management Procedures are conducted in compliance with ISO 14971 Medical devices. Application of risk management to medical devices
- Ensuring 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
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
- 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.
- Experience of pre and post launch IVD or medical device activities
If this is of interest, please do get in touch.
- Medical Devices
- Risk Management
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