Medical Device Remediation Expert

4 days ago

Galway, Galway, Ireland beBeecompliance Full time €60,000 - €80,000
Compliance Specialist for Medical Device Manufacturing

We are seeking a Compliance Specialist to support our remediation program following an FDA 483 observation. The ideal candidate will have experience in medical device manufacturing and quality management, with a strong understanding of process validation and CAPA/NCR management.

Main Responsibilities:

  • Partner with manufacturing process owners to identify and remediate compliance gaps.
  • Support manufacturing process validation activities (IQ/OQ/PQ).
  • Update quality system documentation and technical files to ensure audit readiness.
  • Drive closure of CAPAs and NCRs with effective corrective actions.
  • Provide clear and concise technical writing for quality and manufacturing procedures.
  • Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.

Key Qualifications & Experience:

  • Bachelor's degree in Engineering or Quality-related discipline.
  • 2–5 years of experience in medical device manufacturing, quality, or remediation projects.
  • Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
  • Proven technical writing and documentation skills.
  • Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.
  • Excellent problem-solving skills with the ability to take a problem statement through to a compliant solution.
  • Ability to work onsite in Galway.

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