Quality Assurance Specialist

3 days ago


West Midlands, United Kingdom iO Associates - UKEU Full time

Job Summary

iO Associates - UK/EU is seeking a highly experienced Quality Engineer to join our team. As a Quality Engineer, you will be responsible for reviewing and creating requirements and specifications, validation protocols and reports, risk management documentation, and design change records.

Key Responsibilities

  • Develop and implement quality systems and processes to ensure compliance with ISO 13485 and 21 CFR Part 820 Quality System Regulations
  • Collaborate with cross-functional teams to identify and mitigate risks associated with medical device development
  • Conduct root cause investigations and implement corrective actions to address non-conformities
  • Develop and maintain validation protocols and reports to ensure compliance with regulatory requirements
  • Support the development of design change records and change control processes

Requirements

  • 5+ years of experience in a Quality Engineering role within the medical device industry
  • In-depth knowledge of ISO 13485 and 21 CFR Part 820 Quality System Regulations
  • Proficient in using risk management tools and techniques in compliance with ISO 14971
  • Strong analytical and problem-solving skills
  • Excellent communication and collaboration skills

What We Offer

iO Associates - UK/EU offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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