Quality Engineer

3 weeks ago


Cambridge, United Kingdom BioTalent Full time

Job DescriptionWe’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 ResponsibilitiesLead 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 YouDegree 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....


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