Senior Quality Engineer

4 weeks ago

Galway, Galway, Ireland Sterling Engineering Ltd - Ireland & Europe Full time
Senior Quality Engineer
Location: Galway, Ireland
About the Role
We are looking for an experienced Senior Quality Engineer to join our team in Galway. This role is key to ensuring product and process quality for medical devices in compliance with global regulatory standards.
Key Responsibilities
  • Support new product introductions (NPI) and existing manufacturing operations.
  • Lead non-conformance, CAPA, and complaint investigations.
  • Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and MDR.
  • Collaborate with cross-functional teams on design controls, risk management, and validation.
  • Support internal and external audits and drive continuous improvement.
  • Manage supplier quality and mentor junior team members.
Qualifications
  • Degree in Engineering, Science, or related field.
  • 5+ years' experience in quality within a medical device or regulated industry.
  • Strong knowledge of regulatory standards, CAPA, and validation.
  • Experience with Lean/Six Sigma tools; CQE or Green Belt a plus.
  • Excellent problem-solving and communication skills.
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