Quality Engineer, Compliance Location: Cambridge, UK Hours: 37 hours per week Contract: 12 Months Maximum Supplier Bill Rate: £26.07 per hour Position Overview 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 include generating and reviewing Design History File (DHF) and Risk Management File (RMF) components while partnering with cross‑functional teams at all organisational levels. Key Responsibilities Lead design control and risk management activities for combination product development programmes, ensuring deliverables are authored, approved, and maintained to support clinical trials and commercial licensure. Facilitate effective risk management activities at external design and manufacturing partners. Ensure all development activities comply with internal and external quality and regulatory standards. Provide input into design validation, including human factors engineering assessments. Support assessment of external design companies and suppliers regarding quality systems, facilities, and capabilities. Assist with design and manufacturing investigations for devices used in clinical trials and commercial manufacturing. Contribute to the creat...