Remediation Quality Engineer

3 weeks ago

Galway, Galway, Ireland Oxford Global Resources Full time
Overview

Our client, a leading medical technology company in Galway, is seeking experienced Remediation Quality Engineers / Manufacturing Engineers to support a critical site-wide remediation program following an FDA 483 observation. This role offers a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to drive compliance improvements and process validation initiatives.

Key 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.
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.
  • Must be available to work onsite in Galway.

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