Compliance Quality Engineer – Medical Devices

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

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.