QA Coordinator (ISO13485) — NPI & CAPA Focus

Staffline

Holybourne

On-site

GBP 28,000 - 32,000

Full time

14 days+

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Benefits offered by this job

OnSite staff support

Canteen on site

Free car parking on site

Free hot drinks

Good links to public transport

PPE provided

Shop on site

Suitable for Students

Job summary

Staffline is recruiting for a Quality Assurance Coordinator in Alton to oversee the internal QMS audit programme and drive quality governance. You will conduct internal audits, manage CAPAs, and lead investigations into quality issues while supporting change control and customer inquiries.

The role includes collaboration with NPI and customer-facing quality activities. The ideal candidate has proven QA or quality systems experience in regulated manufacturing (ISO13485 preferred), with internal

Qualifications

Qualified Internal Auditor status is essential.
Experience with internal audits, CAPAs, deviations, change control and customer quality investigations.
GMP experience is desirable.
Degree in science/engineering/manufacturing (desirable).

Responsibilities

Coordinate and manage the internal QMS audit programme.
Conduct internal audits and ensure audit actions are completed.
Lead and support investigations into non-conformances, deviations and quality issues.
Manage the Change Control process.
Investigate customer complaints and quality issues, providing timely responses.
Monitor and verify CAPAs, including effectiveness checks.
Support risk assessments and continuous improvement initiatives.
Provide Quality support to New Product Introduction (NPI) projects.
Participate in line trials and first production reviews from a Quality perspective.
Review and approve packing specifications.
Support Product Quality Reviews (PQRs).
Attend customer meetings as the Quality representative where required.