Quality Engineer

Cpl Life Sciences; Cambridge; Hybrid; GBP 40,000 - 55,000; Full time

Job summary

A leading pharmaceutical research firm is seeking a Quality Engineer – Compliance for a 12-month hybrid contract in the Cambridge area. You will lead design control and risk management activities related to medical devices and combination products, prepare essential documentation, and ensure compliance with regulatory standards. Candidates should have a degree in engineering or a relevant science, along with experience in medical devices. The role offers a flexible work schedule with 2.5 days onsite per week.

Qualifications

• Degree in a relevant science or engineering discipline.
• Experience in medical devices, combination products, pharma, or biotech.
• Knowledge of design controls and risk management.

Responsibilities

• Lead design control and risk management activities.
• Prepare Design History File and risk management documentation.
• Ensure compliance with quality systems and regulatory standards.
• Support design validation activities including human factors.

Skills

Design controls and risk management

Knowledge of ISO 13485

Familiarity with regulatory standards

Experience in medical devices

Education

Degree in science or engineering discipline

Job description

Quality Engineer – Compliance (Medical Devices / Combination Products)

📍 Cambridge area, UK (Hybrid – 2.5 days onsite per week)

📅 12-month contract | ⏱ 37 hours per week

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.

If interested, please apply directly or reach out to [e-mail]