For our client, a leading global medical device manufacturer, we are seeking a Quality Engineer to join a dynamic New Product Development site in Galway, Ireland. 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