Overview
CPL Life Sciences are looking to recruit a Design Controls Engineer to join a global Pharmaceutical company based in Cambridge.
This will be a 12 month contract role (PAYE), based on site in Cambridge.
Responsibilities:
1. Lead design control and risk management activities for medical device combination product development
2. Support effective design control and risk management activities internally, at external design companies, and at related manufacturing facilities/CMOs
3. Generate and approve documentation, ensuring compliance with quality & regulatory standards (internal & external)
4. Provide support to design validation
5. Support in internal & external audits where required
Skills & experience:
6. Hold a relevant degree or proven experience working in a similar role
7. Understanding of working to ISO 13485/ISO 14971/21 CFR 820/21 CFR 4, and the EU Medical Devices Regulation.
8. Experience in medical device combination products and/or medical devices
9. Understand Good Manufacturing Practices (GMP).
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