Quality Assurance Specialist

2 days ago

Galway, Galway, Ireland beBeeEngineer Full time €60,000 - €90,000
Senior Quality Assurance Engineer Role

We are seeking a highly skilled Senior Quality Assurance Engineer to join our dynamic Receiving Inspection team. This onsite role offers the chance to work at the forefront of innovation, supporting the development and validation of inspection processes, fixtures, and quality systems aligned with ISO 13485, GMP, and FDA regulatory standards.

This is a fantastic opportunity for a proactive and detail-oriented individual to make a tangible impact in the medical device sector. You will have the chance to collaborate cross-functionally with R&D, Supplier Quality, and Operations Engineering to drive robust inspection processes.

The successful candidate will have experience in inspection methods, fixture design, and measurement systems analysis (including Gage R&R). Strong CAD software skills (SolidWorks preferred) and statistical analysis tools (e.g., Minitab) are also essential.

Key Responsibilities:

  • Lead the evaluation and implementation of inspection methods and sampling plans for high-volume and complex components.
  • Collaborate cross-functionally with R&D, Supplier Quality, and Operations Engineering to drive robust inspection processes.
  • Design, develop, and qualify custom inspection fixtures and measurement equipment.
  • 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.

What We're Looking For:

  • 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.

This role is ideal for someone with a strong passion for improving human health through high-quality engineering solutions. If you are looking for a challenging and rewarding career, please consider applying for this position.

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