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Medical Device Quality Assurance Specialist

2 months ago


west midlands, United Kingdom iO Associates - UKEU Full time
Job Description

Quality Assurance Engineer for Medical Devices

Competitive Salary: £40 - £50 Outside IR35

6-Month Contract

Onsite

West Midlands

iO Associates is seeking a highly experienced Quality Assurance Engineer for Medical Devices to join our team in the West Midlands.

The successful candidate will be responsible for reviewing and creating requirements and specifications, validation protocols and reports, risk management documentation, and design change records. Additionally, they will support CAPA processes and non-conformance management.

Key Skills:

  • Deep understanding of ISO 13485 and 21 CFR Part 820 Quality System Regulations
  • 5+ Years of experience in a Quality Assurance role within the medical device industry
  • Proficient in using risk management tools and techniques in compliance with ISO 14971
  • Design and Development
  • Change control process
  • Validation activities
  • CAPA Root Cause Investigations

If you are a motivated and experienced Quality Assurance Engineer for Medical Devices, please apply with your most up-to-date CV.