Quality Assurance Specialist

3 weeks ago


Winnersh, United Kingdom BD Full time
About the Role

This is a challenging opportunity for a Quality Assurance Specialist to join our team in the EMEA region. As a key member of our quality assurance team, you will be responsible for conducting quality audits to ensure compliance with domestic and international medical device standards and regulations.

Main Responsibilities
  • Conduct quality audits to assess the effectiveness of quality management systems at various locations.
  • Evaluate the adequacy of evidence against approved audit action plans and develop plans to address inadequate documentation when required.
  • Maintain the audit system software database to record the status of all audits and associated actions.
  • Provide periodic reports to management based on audit statuses and defined metrics.
About You
  • Bachelor's degree in Engineering, Chemistry, Biology, or equivalent discipline; an advanced degree is preferred.
  • Certified Quality Auditor/ISO Lead Auditor Certification or equivalent is required.
  • A minimum of 3 years of work experience in quality assurance, preferably in the medical device industry.
  • Excellent communication and interpersonal skills, with the ability to interact with individuals at various levels of the organization.
Estimated Salary Range

£60,000 - £80,000 per annum, depending on experience.



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