Lead Quality Engineer

4 weeks ago

Galway, Galway, Ireland Guided Solutions Full time

For our client, a leading global medical device manufacturer, we are seeking a Lead Quality Engineer to join a dynamic New Product Development site in Galway, Ireland. The role is hands-on, the only one in Quality, with end-to-end responsibilities for quality, including training and development of production staff. This is a unique opportunity to play a pivotal role in the development and production of innovative medical devices.

This is a multi-functional, hands-on role, ideal for someone who thrives in a dynamic environment where responsibilities span across the Quality Management System (QMS), elements of Quality Control (QC), and cross-functional engineering support. Given the lean nature of the site, the successful candidate will be a key contributor across various quality and operational areas.

Please note that the role requires daily on-site presence.

Key Responsibilities:

  • Oversee and support daily quality activities on the production floor
  • Maintain and improve the Quality Management System (QMS) in line with ISO 13485
  • Conduct internal audits and identify areas for improvement
  • Lead investigations, root cause analysis, and implement CAPAs
  • Review and approve DHRs, validation protocols, and change controls
  • Support risk assessments and product risk management activities
  • Manage supplier quality and conduct supplier audits
  • Train and support teams on quality standards and best practices
  • Monitor key quality metrics and report performance
  • Ensure quality is integrated throughout product development
  • Support audit readiness and regulatory inspections

Requirements:

  • Proven experience in quality engineering in a medical device manufacturing environment
  • Experience working with Quality Management Systems (QMS) and standards such as ISO 13485 and FDA regulations
  • Strong understanding of quality control principles, statistical analysis, and root cause analysis techniques
  • Experience with internal and external audits
  • Experience working in small or fast-paced environments
  • Strong hands-on experience with V&V
  • Ability to work independently and take ownership of quality processes
  • Skilled in coaching and guiding production teams
  • Excellent documentation and communication skills
  • Flexible, hands-on, practical, and comfortable with cross-functional tasks
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