Quality Assurance Manager Manufacturing

15 hours ago


Galway, Galway, Ireland beBeeManufacturing Full time €75,000 - €90,000

About the Role

This position is ideal for a quality expert with experience in manufacturing, supplier oversight, and regulatory compliance. You will work across internal operations and contract manufacturing to ensure product quality, compliance with ISO 13485/FDA 21 CFR 820, and readiness for regulatory inspections.

Main Responsibilities:

  • Oversee quality for electronics/system-level manufacturing with CMs
  • Lead investigations and CAPA for non-conformances
  • Support IQ/OQ/PQ validations and documentation reviews
  • Monitor supplier quality and contribute to audit preparedness
  • Collaborate on regulatory submissions and inspection readiness

Requirements:

  • Degree in Engineering, Quality, or a related discipline
  • 3-7 years of QA or manufacturing quality within a regulated industry
  • Strong knowledge of ISO 13485, FDA QSR, and process validation
  • Experience supporting regulatory audits or working with Regulatory Affairs teams
  • Advantageous: Contract manufacturing experience, CQE, Six Sigma, or auditing certifications


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