Senior Remediation Quality Specialist

1 week ago

Galway City, Ireland beBeeQualityEngineer Full time €60,000 - €80,000
Medical Device Quality Engineer Role

We are seeking a seasoned remediation quality engineer or manufacturing engineer to join our site-wide remediation program following an FDA 483.

  • This role involves focusing on manufacturing process validation, quality system updates, and documentation remediation.
  • As part of the team, you will work directly with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
  • Remediate areas in sequence, update technical files and procedures, and ensure robust validation of manufacturing processes.

Main Responsibilities:

  • Partner with process owners on the floor to capture and remediate issues.
  • Support process validation (IQ/OQ/PQ) and documentation updates.
  • Drive CAPA/NCR closure and implement compliant solutions.
  • Provide technical writing for quality and manufacturing documents.
  • Collaborate cross-functionally to ensure regulatory compliance.

Requirements:

  • An engineering or quality degree with 5-10 years' med-tech experience.
  • A background in remediation, process validation, CAPA, NCRs.
  • Strong technical writing and documentation skills.
  • Knowledge of 21 CFR Part 820, ISO 13485.

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