Senior Manufacturing QA

Senior Manufacturing QA Location : Galway | Industry : Medical Devices | Type : Full-Time A rapidly growing medical device company is seeking a Senior Manufacturing QA to support quality assurance across manufacturing processes and external suppliers, including contract manufacturers. Key Responsibilities : Oversee manufacturing quality for electronic and system-level production Lead root cause investigations and manage CAPAs Support process validations (IQ / OQ / PQ) and documentation reviews Manage supplier quality performance and participate in audits Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and related standards Drive continuous improvement and support internal / external audits Requirements : Bachelor's degree in Engineering, Quality, or a related field 3-7 years in QA or manufacturing in a regulated industry (preferably medical devices) Experience with CAPA, non-conformances, and process validation Strong knowledge of ISO 13485 and FDA QSR Excellent communication skills and attention to detail Preferred : Experience with contract manufacturers Certifications (CQE, Six Sigma, Auditor) Familiarity with QMS / ERP systems (e.g., Greenlight Guru, MasterControl) For more info contact Seamus at Reperio or apply through the link Reperio Human Capital acts as an Employment Agency and an Employment Business. Skills : QA Quality Assurance Manufacturing Medical Devices