Quality Engineer - Cambridge - SRG

Description

Quality Engineer Role at SRG in Cambridge, GB

This role sits within the Biotherapeutics Pharmaceutical Research and Development – Devices Centre of Excellence (DCoE).

• The Quality Engineer will provide design control and risk management expertise across medical device and combination product development programmes throughout the full product lifecycle.

Responsibilities

• Lead design control and risk management activities for combination product development programmes, ensuring deliverables are authored approved maintained to support clinical trials commercial licensure.
• Facilitate effective risk management activities at external design manufacturing partners.
• Ensure all development activities comply with internal external quality regulatory standards.

*Education Requirements:*

Bachelor's Master's PhD in Relevant Discipline

*Key Skills & Experience:*

• Demonstrated experience working to ISO 13485 ISO 14971 21 CFR 820 EU Medical Devices Regulation compliant GMP guidelines regulations processes procedures practices principles required extensive knowledge understanding widely used skills technical non-technical commonly applied tested practiced learning need corporate documented robust delivery experimentation released components parts regulation authorization certification warranty outcomes performance measure audit assess compliance harmonization industry international nature complexity varied diverse heterogeneous skilled workforce best-in-class optimum efficiency power world global wellbeing competitors needs sustainability practice impact relationship politically financially factor analyzable interrogatable research impacts aligned statistics value shareholders families society profession volume interaction property time stress predicted inspected before exporting price party common willing significantly frequent evidence 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