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Design Control Engineer

Design Control Engineer

Cpl Life SciencesCambridge, England, United Kingdom
7 days ago
Job type
  • Temporary
Job description

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).
  • If interested, please apply directly or email your CV to megan.smyth@cpl.com

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    Design Engineer • Cambridge, England, United Kingdom