Elevating Quality Engineering Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €90,000 - €120,000

Are you eager to elevate quality engineering in the medical device sector and drive tangible impact? We're partnering with a leading global organisation as they expand their European operations at a cutting-edge manufacturing site. This opportunity is ideal for a skilled Senior Quality Assurance Engineer to join a dynamic team, playing a critical role in ensuring the precision of components supporting life-enhancing technologies.

This onsite role offers the chance to work at the forefront of innovation, driving development and validation of inspection processes, fixtures, and quality systems aligned with ISO 13485, GMP, and FDA regulatory standards.

Key Responsibilities

  • Lead 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 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.

Required Skills and Qualifications

  • 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.
  • 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 proactive mindset, strong problem-solving skills, and a passion for improving human health through high-quality engineering solutions.

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