Quality Manager

Quality Manager | Medical Devices | Galway (Hybrid) 

Job ID: 101229 

An innovative medical device start-up based in Ireland is seeking an experienced Quality Manager with a Design Assurance focus to join its growing team on a permanent basis. This hybrid role offers the opportunity to play a key quality leadership role as the company advances its technology toward regulatory approval and commercialisation. 

This is an exciting opportunity to join a collaborative, fast-paced environment where quality and design assurance are central to delivering innovative medical technology that improves patient outcomes. The position will suit a senior Quality or Design Assurance professional who thrives in a multidisciplinary start-up setting and enjoys driving compliant product development. 

Your responsibilities as Quality Manager will include:

• Leading and maintaining Design Control processes in compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR 
• Ensuring robust implementation of design inputs, outputs, verification, and validation activities 
• Maintaining Design History Files (DHF) to ensure completeness, accuracy, and audit readiness 
• Driving risk management activities in accordance with ISO 14971, including FMEA and hazard analysis 
• Developing and maintaining Quality Management System (QMS) processes aligned with design assurance activities 
• Overseeing CAPA, deviations, and non-conformance processes related to product development 
• Leading internal and external audits, including design-focused regulatory inspections 
• Supporting regulatory submissions and interfacing with regulatory authorities on design-related matters 
• Driving continuous improvement using quality metrics and design performance data 
• Mentoring QA/RA and Design Assurance team members and supporting cross-functional collaboration 
• Working closely with contract manufacturing partners to ensure quality alignment 

To be successful as Quality Manager, you will demonstrate:

• 10+ years’ experience in Quality Assurance, Regulatory Affairs, or Design Assurance within medical devices 
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and Design Control requirements 
• Hands-on experience developing or maintaining QMS processes 
• Experience supporting or leading regulatory authority audits (FDA experience advantageous) 
• Familiarity with eQMS systems and quality training delivery 
• Proven ability to influence design decisions through data-driven quality insights 
• Strong leadership, communication, and stakeholder engagement skills 
• Experience working within start-up or scaling environments is highly desirable 

This is an excellent opportunity to make a long-term impact within a growing medical device company during a critical stage of product development and market readiness. 

QA Manager | Design Assurance | Quality Manager | Quality Assurance | Medical Devices | ISO 13485 | FDA 21 CFR Part 820 | EU MDR | ISO 14971 | Design Controls | DHF | QMS | CAPA | Risk Management | Ireland | Hybrid | Start-up | Quality Leadership