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Senior Quality Assurance Lead

1 month ago

Hertfordshire, United Kingdom X4 Life Sciences Full time

X4 Life Sciences is seeking an experienced Senior Quality Assurance Lead to join their team in Hertfordshire. This role offers a competitive salary of up to £65,000 and the opportunity to work on exciting projects in the medical device industry.

About the Role:

  • This position will be responsible for maintaining the company's Quality Management System, ensuring compliance with ISO 13485 standards and identifying areas for improvement.
  • The successful candidate will conduct regular audits of internal systems, lead external quality assurance audits, and oversee the quality department to ensure seamless operations.
  • We are looking for someone with strong knowledge of quality standards, including ISO 13485, UKCA, and MDR, as well as experience working within ISO quality systems.
  • A self-driven individual with excellent communication skills and the ability to work independently is essential for this role.
  • The ideal candidate will have a minimum of 5 years' experience in a similar supervisory or multi-functional role, with a background in the medical device industry being a plus.

Key Responsibilities:

  • Maintain the Quality Management System by recording incidents, implementing corrective actions, and tracking improvements.
  • Conduct audits of internal systems to ensure compliance with ISO 13485.
  • Lead external quality assurance audits when required.
  • Oversee the quality department by setting clear job expectations, planning, and monitoring team performance.

Requirements:

  • Minimum of 5 years' experience 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 excellent communication skills and ability to work independently.