Quality Engineer

Quality Engineer, Compliance

Location:

Cambridge, UK (Hybrid 2.5 days per week onsite) About the Role Join the Biotherapeutics Pharmaceutical R&D Devices Centre of Excellence, where youll play a key role in ensuring quality and compliance for medical devices and combination products throughout their lifecycle. This position focuses on design control and risk management, supporting development programs from early design through to commercial launch. Youll work closely with cross-functional teams and external partners to maintain the highest standards of quality and regulatory compliance.

Key Responsibilities Lead design control and risk management activities for combination product development, ensuring all deliverables are accurate, approved, and audit ready. Facilitate risk management processes with external design and manufacturing partners. Ensure compliance with internal and external quality and regulatory standards (ISO 13485, ISO 14971, 21 CFR 820, EU MDR). Provide input into design validation activities, including Human Factors Engineering assessments.