High Salary Quality Manager

4 weeks ago

Galway, Galway, Ireland Life Science Recruitment Ltd Full time

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. About You 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. Whats on Offer 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. If interested in discussing further please contact James Cassidy or call in confidence

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