Process Excellence Engineer

4 days ago

Cork, Cork, Ireland beBeeManufacturing Full time €60,000 - €80,000
Job Title: Process Excellence Engineer

We are seeking experienced professionals to support a site-wide remediation program following an FDA 483.

  • Partner with process owners on the floor to identify and rectify 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.
Key Requirements:
  • Bachelor's degree in Engineering or Quality discipline with 5-10 years' experience in med-tech.
  • Background in remediation, process validation, CAPA, NCRs.
  • Strong technical writing and documentation skills.
  • Familiarity with 21 CFR Part 820, ISO 13485.

The ideal candidate will possess excellent analytical and problem-solving skills, with the ability to communicate effectively across departments.

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