Quality Assurance Manager

3 weeks ago


St Albans, United Kingdom X4 Life Sciences Full time

Exciting new opportunity: A growing Medical Device company are looking to add a Quality Manager to their team based in Hertfordshire. This role will be worked on site 5 days a week and are offering a salary of up to £50,000.


Responsibilities include:

  • Maintain the Quality Management System by recording incidents, implementing corrective actions and tracking improvements.
  • Conduct audits of the internal systems 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.


Knowledge, skills and abilities:

  • Minimum of 5 years experince in a similar supervisory or multi-functional role.
  • Strong understanding of quality standards, including ISO 13485, UKCA, and MDR.
  • Background in working within ISO quality systems (such as ISO 9001 or 13485), with preference for 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.


Please apply to this job posting with your resume attached and I will give you a call



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