Medical Device Quality Assurance Specialist

4 days ago


Haddenham, Buckinghamshire, United Kingdom Newton Colmore Full time

Quality Assurance Role for a Growing Medical Devices Organisation

We are currently seeking a Quality Assurance professional for a dynamic and innovative Medical Devices company. The organisation is developing a medical device that is revolutionising the lives of thousands of people and has received significant media attention due to its impressive features.

You will be reporting to the Quality Assurance Director and collaborating with various Medical Devices experts, including Mechanical Engineers, Physicists, Electronics Engineers, Software Engineers, and other professionals. Your primary focus will be on ensuring the quality and compliance of Medical Devices to ISO 13485 standards, although knowledge of 21 CFR Part 820 or regulatory affairs expertise would also be advantageous.

  • Implementing and maintaining a Quality Management System (QMS)
  • Validating Medical Devices to ensure compliance with regulatory requirements
  • Conducting risk assessments and management activities
  • Performing internal audits to ensure quality and compliance
  • Other duties typical of a Quality Assurance role

The role is based in a location that offers a great work-life balance, with easy access to amenities and transportation links. We welcome applications from candidates with a degree in a relevant field, although we also consider candidates with alternative routes into a Medical Devices career.

This role offers a challenging and rewarding opportunity, with a competitive package that includes a shares/equity scheme, life assurance, pension, private healthcare, income protection insurance, and an employer discount scheme.



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