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 creation of regulatory submission data for assigned device projects.
Support internal and external audits of the DCoE Quality Management System.
Education, Skills & Experience Requirements
Education
One of the following is required:
BSc in a relevant science/engineering discipline with minimum 2 years' experience in pharmaceutical combination product and/or device industries
MSc in a relevant discipline with minimum 2 years' experience
PhD in a relevant science/engineering disciplineRelevant fields include: chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering, or related areas.
Experience & Knowledge
Demonstrated experience working to ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
Proven background in design controls and risk management for combination products.
Familiarity with Human Factors Engineering / Usability Engineering.
Understanding of device assembly and manufacturing processes.
Technical Skills
Working knowledge of:
ISO 9001
ISO 13485
ISO 14971
21 CFR 820
21 CFR 4
EU MDR
Familiarity with:
EN 62366 (Usability Engineering)
EN 60601 (Electrical Medical Equipment)
EN 62304 (Medical Device Software)
Ability to apply established procedures consistently.
Strong attention to detail and accuracy.
Able to prioritise and manage multiple tasks simultaneously.
Capable of working independently with minimal supervision.
Effective communicator with strong interpersonal skills.
Proficiency in standard office software (Word, Excel, PowerPoint).
Understanding of Good Manufacturing Practices (GMP).
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