Quality Assurance Lead for Medical Devices

3 days ago


Hertfordshire, United Kingdom X4 Life Sciences Full time

Exciting new opportunity at X4 Life Sciences: A growing company based in Hertfordshire is looking to add a Quality Manager to their team. This role will be worked on site 5 days a week and offers a salary of up to £65,000.

Key Responsibilities:

  • Maintain the Quality Management System by recording incidents, implementing corrective actions and tracking improvements.
  • Conduct internal audits to ensure compliance with ISO 13485.
  • Lead external quality assurance audits when required.
  • Identify, document and investigate non-conformances, determine root causes, and track resolutions in weekly meetings.
  • Monitor the production cycle, performing regular tests to detect issues early in the process.
  • Inspect product materials and test finished goods to ensure they meet specifications.
  • Lead the transition to automated test equipment for quality testing, minimizing manual testing by operators.
  • Review production Work Instructions (WIs) to ensure they are completed accurately and comply with standards.
  • Oversee the quality department by setting clear job expectations, planning and monitoring team performance, and appraising results.

Requirements:

  • A minimum of 5 years experience in a similar supervisory or multi-functional role.
  • A strong understanding of quality standards, including ISO 13485, UKCA, and MDR.
  • A background in working within ISO quality systems, such as ISO 9001 or 13485, with a preference for the medical device industry.
  • Internal auditor certification in ISO 9001 or 13485 is a plus.
  • Self-driven with the ability to work independently and effectively manage tasks.

X4 Life Sciences is a dynamic company offering a competitive salary package including benefits.



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