Medical Device Quality Assurance Professional

1 day ago


St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time
Job Title: Medical Device Quality Assurance Professional

This position offers a competitive salary ranging from £40,000 to £45,000.

X4 Life Sciences is seeking a skilled medical device quality assurance professional to join its expanding quality team. As a key member of the team, you will play a vital role in ensuring the delivery of high-quality products.

About the Position:
  • Take ownership of maintaining the QMS, overseeing various aspects such as CAPA, RCA, change control, document control, risk assessments, and internal, supplier, and customer/notified body audits.
  • Collaborate with NPI project teams to drive validation processes, including IQ/OQ/PQ.
  • Act as the primary point of contact for a portfolio of customers, addressing all quality-related inquiries and concerns.
  • Prepare detailed reports analyzing data to inform improvement initiatives.
Essential Skills and Qualifications:
  • Degree qualification or relevant experience in a quality assurance role.
  • Proven understanding of ISO 9001 or ISO 13485:2016 standards.
  • Experience in auditing and quality assurance roles.
  • Able to work effectively both independently and as part of a team.

The successful candidate will possess excellent communication and analytical skills, with a strong attention to detail.



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