Quality Engineer – Medical Devices

Overview

In this role you ensure quality across medical device projects in a growing Cambridge-based team. You will focus on quality assurance under ISO 13485, with advantageous knowledge of EN 60601, and contribute to technical files and testing documentation. You’ll collaborate with engineers from multiple disciplines to apply Design Assurance where relevant. This is an opportunity to influence regulatory compliance and product quality across diverse medical devices. You will join a company that values growth, cross-functional teamwork, and a strong quality culture.

Pay / Benefits

• excellent starting salary
• bonus
• generous pension
• life assurance
• healthcare

Responsibilities

• QA of medical devices to ISO 13485 standards
• Create technical files and testing documentation
• Apply Design Assurance practices where relevant
• Collaborate with Mechanical, Physics, Electronics, and Software teams
• Support regulatory compliance activities
• Contribute to quality improvements across projects

Key requirements

• experience in quality engineering for medical devices
• knowledge of ISO 13485
• optional knowledge of EN 60601 is advantageous
• degree aligned with medical devices quality engineering (or alternative routes considered)
• ability to work with cross-functional teams

• collaboration
• problem-solving
• communication
• ISO 13485 quality assurance
• Design Assurance
• technical file creation

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