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Quality Assurance Specialist

2 months ago


Didcot, Oxfordshire, United Kingdom Newton Colmore Full time
Quality Assurance Specialist - Medical Devices

We are seeking a dedicated Quality Assurance Specialist to join a dynamic and innovative organization in the medical devices sector.

This company is at the forefront of developing a groundbreaking medical device that is positively impacting the lives of many individuals. Their recent achievements have garnered attention in various media outlets, showcasing the exceptional quality of their work.


In this role, you will report directly to the Quality Assurance Manager and work closely with a diverse team of experts, including Mechanical Engineers, Physicists, Electronics Engineers, Software Engineers, and other professionals in the field.

Your main responsibilities will include ensuring the quality of medical devices in compliance with ISO 13485 standards. Familiarity with 21 CFR Part 820 or knowledge of regulatory affairs will be considered a plus.


Key responsibilities include:

  • Implementing and maintaining the Quality Management System (QMS)
  • Conducting validation processes for medical devices
  • Managing risk assessments
  • Performing internal audits
  • Engaging in various tasks typical of a Quality Assurance role


The organization is in the process of relocating, and initially, this position will be hybrid, requiring attendance at the current site a few days a week.

We are looking for candidates with a degree that has led them to a career in Quality Assurance within the medical devices industry. However, we are also open to considering alternative pathways into this field.


This position presents an exciting and rewarding opportunity, offering a comprehensive benefits package that includes a share/equity scheme, life insurance, pension plan, private healthcare, income protection insurance, and an employee discount program.

For further details, please reach out to our recruitment team at Newton Colmore, who will be happy to assist you.