Engineering - Quality Engineer
- United Kingdom
- Contract
- Full-time
- Job type:
Manufacturing * Location:
United KingdomCambridge, EnglandPosting date: 26 Aug 2025Reference: 66754Are you passionate about quality and precision? Join our client with this engineering role and help ensure top-tier standards every day.Proclinical is seeking a skilled engineer to join a dynamic team in Cambridge, UK. In this role, you will provide expertise in design control and risk management for medical devices and combination products throughout their lifecycle. You will collaborate with cross-functional teams to ensure compliance with quality and regulatory standards while supporting clinical trials and commercial licensures. This is an exciting opportunity to contribute to innovative biotherapeutic solutions.Responsibilities:
- Lead design control and risk management activities for combination product development programs.
- Author, review, and maintain design history files and risk management documentation.
- Facilitate risk management activities with external design companies and manufacturing facilities.
- Ensure compliance with internal and external quality and regulatory standards.
- Support design validation processes, including human factors engineering assessments.
- Assess external design companies and suppliers for quality systems and capabilities.
- Investigate device design and manufacturing issues from clinical trials and commercial use.
- Contribute to regulatory submission data and content for assigned projects.
- Support internal and external audits of the Quality Management System.
- Identify and implement strategies to improve combination product systems.
- Background in science or engineering (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, or related disciplines).
- Expertise in ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
- Experience in design controls and risk management for combination products.
- Familiarity with Human Factors Engineering and usability engineering principles.
- Knowledge of device assembly and manufacturing processes.
- Strong analytical skills for complex data analysis.
- Proficiency in project management methodologies and technical leadership.
- Excellent communication and collaboration skills.
- Proficiency in general computer software (e.g., word processing, spreadsheets, presentations).
- Understanding of Good Manufacturing Practices (GMP).