Quality Assurance Specialist
3 weeks ago
This role is an exciting opportunity to join a leading Medical Device company, X4 Life Sciences, in expanding their Quality team.
About the Role
The successful candidate will be responsible for maintaining our QMS, including CAPA, RCA, change control, document control, risk assessments, and audits. They will also play a key role in NPI project teams by driving validation processes.
Key Responsibilities
• Support the maintenance of our QMS, including CAPA, RCA, change control, document control, risk assessments, and internal, supplier, and customer/notified body audits.
• Play a key role in NPI project teams by driving validation processes, including IQ/OQ/PQ.
• Serve as the primary point of contact for a portfolio of customers, handling all quality-related correspondence.
• Produce reports analyzing data to help drive improvement.
Experience and Qualifications Required
• 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.
Estimated Salary: £42,000 - £47,000 per annum.
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