Quality Manager – High-Growth Medical Device Start-Up – Galway

About the Company
Our client a rapidly growing, well-funded medical device start-up based in Galway, entering an exciting new phase of operational scale-up. With a high-potential product pipeline and a leadership team experienced in successful start-up growth and commercialization, are building out their core team to support ongoing manufacturing, development, and expansion activities.
The Opportunity
Client are seeking a hands-on and driven Quality Manager to take ownership of quality function. As they transition into a more operationally mature phase, this role will be central to ensuring robust, scalable quality systems are in place to support both internal manufacturing and our external supply chain.

Key Responsibilities

• Maintain and evolve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR 820, and other applicable regulations.
• Oversee all quality aspects of internal manufacturing operations, including batch release, in-process controls, and product inspections.
• Provide quality oversight for subcontract manufacturing partners, including audits, quality agreements, and supplier performance management.
• Lead internal and external audits, manage CAPAs, and ensure continuous improvement across all quality processes.
• Support internal R&D, engineering, and operations teams with quality input during project development and tech transfer.
• Act as the quality lead for product lifecycle activities from development through commercialization.
• Work closely with regulatory affairs to ensure alignment across compliance and submission activities.

• 5+ years’ experience in quality assurance within the medical device industry, ideally with Class II/III devices.
• Strong working knowledge of ISO 13485, FDA QSR, MDR, and relevant global regulatory frameworks.
• Experience with both internal and contract manufacturing environments.
• Demonstrated ability to build, maintain, and improve quality systems in a fast-paced setting.
• Practical, solution-oriented approach with excellent communication and collaboration skills.
• Degree in Engineering, Science, or a related technical field.

• A high-impact role within a well-backed, innovation-driven start-up.
• Opportunity to shape and lead the quality function during a critical phase of growth.
• Competitive salary, benefits, and equity participation.
• A dynamic and collaborative environment where your contributions directly influence company success.