
Quality Engineer
- Cambridge
- £18.79-29.12 per hour
- Permanent
- Full-time
- Lead design control and risk management activities for combination product development programs
- Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects
- Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external
- Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture
- Support the generation of all regulatory submission data and content for assigned device projects
- Hold a relevant scientific or engineering degree, or have equivalent working experience
- History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation
- Familiar with Human Factors Engineering - Usability Engineering
- Familiar with device assembling manufacturing processes
- Experience in design controls for combination products