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Quality technician

Galway
Cregg Recruitment
Quality technician
Posted: 24 October
Offer description

Job Purpose: Our client a medical device company are seeking a QA Technician to provide day-to-day quality support on the manufacturing lines. This role ensures compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and the internal Quality Management System. You will be responsible for production audits, non-conformance handling, quality metrics reporting, and supporting continuous improvement and compliance activities. Key Responsibilities: Perform production audits, inspections, and ensure Good Manufacturing & Documentation Practices (GMP/GDP) Manage non-conforming materials and support root cause investigations Maintain and report quality metrics Support internal/external audits and regulatory compliance Assist in documentation, process improvements, and lean initiatives Education and Experience: Degree in a quality-related discipline is desirable 25 years experience in a regulated manufacturing environment (Medical Device or Pharma) Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR Excellent communication and documentation skills Proficient in Microsoft Office

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