Product Validation Specialist

2 days ago


St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time
Job Title: Product Validation Specialist

The salary for this role is estimated to be around £40,000 - £45,000.

X4 Life Sciences is a growing medical device company looking to expand its quality team with the addition of a product validation specialist. This is an exciting opportunity to join an established market leader with an international reputation.

About the Role:
  • Support the maintenance of the QMS and lead various aspects, including CAPA, RCA, change control, document control, risk assessments, and internal, supplier, and customer/notified body audits.
  • Drive validation processes, including IQ/OQ/PQ, in NPI project teams.
  • Serve as the primary point of contact for a portfolio of customers, handling all quality-related correspondence.
  • Analyze data to produce reports that help drive improvement.
Requirements:
  • Degree qualified or equivalent experience in a similar role.
  • Strong understanding of ISO 9001 or ISO 13485:2016 standards.
  • Demonstrated experience in a Quality Assurance role, which includes auditing.
  • Ability to work independently as well as collaboratively within a team.

The ideal candidate will have a strong background in quality assurance and a passion for driving improvement.



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