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Medical Device Quality Assurance Specialist

2 months 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 we are looking for a talented individual to help us achieve our goals.

You will be reporting into 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 Quality Assurance of Medical Devices to ISO 13485 standards, although knowledge of 21 CFR Part 820 or regulatory affairs knowledge would be advantageous.

Key responsibilities include:

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

We are looking for a candidate with a degree that led them into a Medical Devices Quality Engineering career, although we would also consider candidates with alternative routes into the field.

This role offers an exciting and challenging opportunity, with a competitive salary and benefits package, including a shares/equity scheme, life assurance, pension, private healthcare, income protection insurance, and an employer discount scheme.

For more information, please contact Andrew Welsh, Director of Medical Devices, Biotech and Science recruitment specialists, Newton Colmore, or submit an application, and a member of our team will be in touch with you.