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
* 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 role
* Understanding 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 devices
* Understand Good Manufacturing Practices (GMP).
Application
If interested, please apply directly or email your CV to megan.smyth@cpl.com
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