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.