Blackfield Associates are working with an exciting Medical Devices organisation who are looking to grow their QA/RA team.
Reporting to the Complaints Manager, the core function of the role will be to investigate product complaints, plan and complete investigations into the root cause of failures received via the complaints process. The key responsibilities are as follows:
- Investigation of device issues, determining and reporting the root cause and recommending corrective actions.
- Maintaining safe contamination control and quarantining of products where required
- Assisting with the collection and review of post-market surveillance data, such as complaint trend analysis
- Assisting with periodic risk reviews and Health Hazard Evaluations
To be considered for the role candidates must have both a Quality and Engineering background, with experience working within regulated environments, including maintaining GMP and handling complaints investigations. A working knowledge of root cause investigations on medical devices is essential. Working knowledge of FDA, EU and UK Medical Device regulations is expected, as well as an understanding of control of biological contamination.