Quality Engineer
20 hours ago
Cambridge
We’re seeking a Quality Engineer to join a leading Medical Device company in Cambridgeshire. The role focuses on providing design control and risk management expertise across medical device and combination product development programmes. Key Responsibilities • Lead design control and risk management activities supporting development, clinical, and commercial programmes., • Ensure compliance with internal and external quality and regulatory standards., • Collaborate with external design and manufacturing partners to support risk management and design verification., • Contribute to human factors engineering and usability assessments., • Support regulatory submissions, audits, and investigations related to device design and manufacturing. About You • Degree in a relevant science or engineering discipline (BSc/MSc/PhD)., • Experience in combination product or medical device development., • Strong knowledge of ISO 13485, ISO 14971, 21 CFR 820/4, and EU MDR., • Familiarity with EN 62366, EN 60601, and EN 62304., • Detail-oriented, self-motivated, and able to manage multiple priorities., • Excellent communication and cross-functional collaboration skills.