Manufacturing Quality Assurance Specialist

2 days ago


Galway, Galway, Ireland beBeeRegulation Full time €60,000 - €80,000
Manufacturing Quality Assurance Specialist

Our organization is seeking an experienced Manufacturing Quality Assurance specialist to support a comprehensive remediation program following an FDA inspection. This role will focus on validating manufacturing processes, updating quality systems, and ensuring accurate documentation.

The consultant will be based onsite and work closely with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.

The project involves tackling remediation areas in sequence, updating technical files and procedures, and ensuring robust validation of manufacturing processes.

  • Collaborate with process owners on the floor to capture and address issues.
  • Support process validation (IQ/OQ/PQ) and documentation updates.
  • Drive CAPA/NCR closure and implement compliant solutions.
  • Develop high-quality technical documents for quality and manufacturing.
  • Work collaboratively across functions to ensure regulatory compliance.

Requirements

  • Engineering or Quality degree with 5-10 years' experience in medical device industry.
  • Background in remediation, process validation, CAPA, NCRs.
  • Strong writing and documentation skills.
  • Familiarity with 21 CFR Part 820 and ISO 13485.


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