Senior Quality Assurance Specialist

3 weeks ago


Middlesbrough, United Kingdom Austin Vita Full time

Job Title: Senior Quality Assurance Specialist

Job Summary: We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Austin Fraser. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for maintaining compliance with relevant regulations and standards.

Main Responsibilities:

  • Conduct internal audits to ensure compliance with ISO 13485, 21 CFR, MDD/MDR, and UKCA regulations.
  • Log, investigate, and document non-conformities, and ensure that appropriate action is taken to correct the issue and prevent recurrence.
  • Prepare and implement corrective and preventative action reports (CAPA), non-conformity reports (NC), and regulatory reporting.
  • Assist in the implementation of compliant processes and QMS documentation across multiple sites.
  • Review and implement third-party agreements.

Requirements:

  • Experience of working in a quality environment, within the medical device industry.
  • Experience of auditing to ISO 13485, preferably at lead auditor level.
  • Experience of generating and completing CAPA/complaints and root cause analysis.

About Us: Austin Fraser is a global medical device company based in North Yorkshire. We are committed to being an equal opportunities employer and encourage applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.



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