Advanced Manufacturing Specialist

2 weeks ago


Galway, Galway, Ireland beBeeQuality Full time €81,928 - €121,232

Senior Quality Assurance Engineer plays a critical role in ensuring the quality and precision of components supporting life-enhancing technologies.

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This is an opportunity for a skilled engineer to join a dynamic team, leading the evaluation and implementation of inspection methods and sampling plans for high-volume and complex components.

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Key responsibilities include collaborating cross-functionally with R&D, Supplier Quality, and Operations Engineering to drive robust inspection processes, designing, developing, and qualifying custom inspection fixtures and measurement equipment, conducting Gage R&R studies and measurement system analyses to ensure repeatability and accuracy, developing and validating test methods in compliance with industry standards and regulatory requirements, investigating and resolving Out-of-Spec (OOS) events and driving root cause analysis and CAPA activities, supporting the training and supervision of lab personnel in inspection techniques and quality standards, and managing documentation including Change Orders and Non-Conformance Material Reports (NCMRs), ensuring traceability and audit readiness.

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A bachelor's degree in engineering or a related technical discipline is required, along with 5+ years of quality engineering experience within the medical device, biotech, or pharmaceutical sectors.

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This role requires strong experience in inspection methods, fixture design, and measurement systems analysis (including Gage R&R), proficiency in CAD software (SolidWorks preferred) and statistical analysis tools (Minitab), working knowledge of GD&T, mechanical drawings, and regulatory frameworks including ISO 13485 & FDA 21 CFR Part 820.

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A proactive mindset, strong problem-solving skills, and a passion for improving human health through high-quality engineering solutions are essential for this role.

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Key Responsibilities:

", "
  • ", "
  • Lead the evaluation and implementation of inspection methods and sampling plans.", "
  • Collaborate cross-functionally with R&D, Supplier Quality, and Operations Engineering.", "
  • Design, develop, and qualify custom inspection fixtures and measurement equipment.", "
  • Conduct Gage R&R studies and measurement system analyses.", "
  • Develop and validate test methods.", "
  • Investigate and resolve Out-of-Spec (OOS) events.", "
  • Drive root cause analysis and CAPA activities.", "
  • SUPport the training and supervision of lab personnel.", "
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