Lead Quality Assurance Specialist

3 days ago

Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000
Senior Quality Assurance Engineer Job Overview

As a seasoned Senior Quality Assurance Engineer, you will play a pivotal role in ensuring the highest standards of quality across our organization.

  • Develop and implement inspection methods and sampling plans for high-volume and complex components to guarantee consistency and accuracy.
  • Collaborate closely with cross-functional teams including R&D, Supplier Quality, and Operations Engineering to drive efficient and effective inspection processes.
  • Design, develop, and qualify custom inspection fixtures and measurement equipment to support quality control initiatives.
  • Conduct Gage R&R studies and measurement system analyses to ensure repeatability and accuracy.
  • Develop and validate test methods in compliance with industry standards and regulatory requirements.
  • Investigate and resolve Out-of-Spec (OOS) events and drive root cause analysis and CAPA activities.
  • Support the training and supervision of lab personnel in inspection techniques and quality standards.
  • Manage documentation including Change Orders and Non-Conformance Material Reports (NCMRs), ensuring traceability and audit readiness.

Requirements:

  • Bachelor's or Master's degree in Engineering or a related technical discipline.
  • 5+ years of quality engineering experience within the medical device, biotech, or pharmaceutical sectors.
  • Strong experience in inspection methods, fixture design, and measurement systems analysis (including Gage R&R).
  • Proficient in CAD software (SolidWorks preferred) and statistical analysis tools (e.g., Minitab).
  • Working knowledge of GD&T, mechanical drawings, and regulatory frameworks including ISO 13485 & FDA 21 CFR Part 820.

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