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.