Experienced Manufacturing Professional Wanted

15 hours ago

Galway, Galway, Ireland beBeeManufacturing Full time €80,000 - €100,000
Manufacturing Engineer Opportunity

We are seeking a highly experienced Manufacturing Engineer to join our team in Galway. As a key member of our manufacturing team, you will play a critical role in driving 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:

  • Bachelors degree in Engineering or Quality-related discipline.
  • 25 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.

What We Offer:

  • A fantastic opportunity to work directly onsite in Galway.
  • A competitive compensation package.
  • Ongoing training and development opportunities.

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