Quality Engineer, Compliance

About the Role

A global biopharma organisation is growing its Devices Centre of Excellence in Cambridge, UK and is looking for a Quality Engineer (Compliance) to support medical device and drug-device combination product programmes across the product lifecycle from early development through to clinical and commercial supply.

This is a hands‑on, collaborative role for someone who enjoys being close to the development teams, keeping work audit‑ready, and ensuring design control and risk management activities meet internal and global regulatory standards.

Key Responsibilities

• Leading design control and risk management activities for assigned programmes, ensuring deliverables are accurate, approved and maintained.
• Supporting and facilitating risk management with external design and manufacturing partners.
• Ensuring compliance with key standards and regulations including ISO 13485, ISO 14971, 21 CFR 820, EU MDR (and related ...

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