Medical Device Quality Assurance Specialist

3 weeks ago


Aylesbury, Buckinghamshire, United Kingdom Newton Colmore Consulting Full time
Quality Engineer - Aylesbury - Start-up Medical Devices

We are seeking a highly skilled Quality Engineer to join our growing start-up Medical Devices organisation. The company is developing a medical device that is revolutionising the lives of thousands of people and has recently gained significant media attention.

As a Quality Engineer, you will be reporting to the Quality Assurance Manager and collaborating with a team of Medical Devices experts, including Mechanical Engineers, Physicists, Electronics Engineers, Software Engineers, and other professionals. Your primary focus will be on ensuring the quality of Medical Devices to ISO 13485 standards, with knowledge of 21 CFR Part 820 or regulatory affairs also being advantageous.

Key responsibilities will include:

  • Implementing Quality Management Systems (QMS)
  • Validating Medical Devices
  • Risk management
  • Other duties relevant to a Quality Engineer role

We are looking for a candidate with a degree that has led them into a Medical Devices Quality Engineering career. However, if you have another route into a Medical Devices role, we would still be keen to hear from you.

This role offers an exciting and challenging opportunity and will also reward you with a shares/equity scheme, life assurance, pension, private healthcare, income protection insurance, and an employer discount scheme.

For more information, please feel free to contact Andrew Welsh, Director of Medical Devices, Biotech and Science recruitment specialists, Newton Colmore, on +44 121 268 2240 or submit an application, and a member of our team at Newton Colmore will be in touch with you.



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