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 :
- Lead design control and risk management activities for medical device combination product development
- Support effective design control and risk management activities internally, at external design companies, and at related manufacturing facilities / CMOs
- Generate and approve documentation, ensuring compliance with quality & regulatory standards (internal & external)
- Provide support to design validation
- Support in internal & external audits where required
Skills & experience :
Hold a relevant degree or proven experience working in a similar roleUnderstanding of working to ISO 13485 / ISO 14971 / 21 CFR 820 / 21 CFR 4, and the EU Medical Devices Regulation.Experience in medical device combination products and / or medical devicesUnderstand Good Manufacturing Practices (GMP).If interested, please apply directly or email your CV to megan.smyth@cpl.com