Senior Quality & Compliance Engineer (Med Device/Combo)

Cpl Life Sciences; Cambridge; On-site; GBP 83,000 - 111,000; Full time

Job summary

A global Pharmaceutical organisation is seeking a Quality & Compliance Engineer for a contract position in Cambridge. The ideal candidate will have significant experience in risk management and design control, especially within medical device development. This role will involve working on combination products, supporting product development from design through to manufacturing, ensuring compliance with quality standards. Interested candidates should apply directly or email their CV.

Qualifications

• Minimum of 5 years of relevant experience in pharmaceutical combination product or device industries.
• Knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
• Ideally experience in design controls for combination products.

Responsibilities

• Lead risk management and design control activities for product development.
• Ensure compliance with quality and regulatory standards.
• Support design validation and human factors engineering teams.

Skills

Risk management (ISO 14971)

Design control activities

Quality and regulatory compliance

Human Factors Engineering

Medical device manufacturing processes

Education

BSc in appropriate science & engineering discipline

Job description

A global Pharmaceutical organisation is seeking a Quality & Compliance Engineer for a contract position in Cambridge. The ideal candidate will have significant experience in risk management and design control, especially within medical device development. This role will involve working on combination products, supporting product development from design through to manufacturing, ensuring compliance with quality standards. Interested candidates should apply directly or email their CV.