Senior Quality Engineer

Senior Quality Engineer | Galway | Stroke MedTech

A high-growth, Galway-based medical device company is hiring a Senior Quality Engineer to join its expanding team. The company develops innovative catheter-based technology designed to treat Acute Ischemic Stroke, with a clear mission to significantly reduce post-stroke disability worldwide.

This is an opportunity to join a collaborative, inclusive environment where employees have real influence, learning is continuous, and performance is recognised. The role is based on the west side of Galway City.

The Senior Quality Engineer will play a key role across quality systems, supplier quality, and manufacturing, with a strong focus on continuous improvement and regulatory compliance. You will partner cross-functionally to enhance product and process performance while ensuring the highest standards of patient safety.

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• Support and maintain a Quality Management System compliant with EU MDR (2017/745), FDA 21 CFR 820, and ISO 13485
  
• Lead supplier and outsourced manufacturer quality activities
  
• Drive risk management activities in line with ISO 14971
  
• Lead process verification and validation activities
  
• Manage non-conformances and CAPAs, including root cause investigation and corrective actions
  
• Support product transfers and manufacturing quality deliverables
  
• Apply risk-based problem solving to ensure product quality and patient safety
  
• Monitor and analyse KPIs to drive continuous improvement
  

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• Degree in Engineering or Science
  
• 5+ years’ experience in quality or manufacturing within medical devices
  
• Strong working knowledge of EU & US medical device regulations and GMP
  
• Demonstrated experience with risk management (ISO 14971)
  
• Proven ability to balance product supply continuity with regulatory compliance
  
• Strong stakeholder engagement and cross-functional collaboration skills
  
• Hands-on mindset with a proactive, solutions-driven approach