Quality Engineer

12m Contract

Cambridge (2.5 days per week average on site)

We are looking for a Quality Engineer - Compliance to support medical device and combination product development programmes within a leading pharmaceutical R&D environment.

Key Responsibilities

• Lead and support design control and risk management activities across device and combination product programmes.
• Prepare and review Design History File (DHF) and risk management documentation.
• Ensure compliance with quality systems and regulatory standards.
• Support design validation activities, including human factors / usability engineering.
• Assist with regulatory submissions, supplier assessments, and quality audits.
• Support investigations related to clinical and commercial device manufacturing.

Requirements

• Degree in a relevant science or engineering discipline.
• Experience in medical devices, combination products, pharma, or biotech.
• Knowledge of design controls and risk management.
• Familiarity with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4, and EU MDR.
• Understanding of GMP and device development processes is beneficial.

If you have experience working in regulated device or combination product environments and are interested in a hybrid contract role in the Cambridge area, please apply or get in touch.