Quality Director Medical Device Start-Up Galway About the Company Our client is a dynamic, well-funded medical device start-up based in Galway, poised for significant growth as it moves further into the operational space. Led by a highly experienced management team with a proven track record of success in the start-up ecosystem, the company is entering an exciting phase of expansion and scale-up. The Opportunity We are seeking a Quality Director with strong strategic vision and leadership capabilities to join the executive team. This is a pivotal role where you will shape and execute the company's quality strategy, oversee regulatory compliance, and drive operational excellence as the business grows both domestically and internationally. Key Responsibilities Lead the development and execution of the companys Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR 820, MDR, and other applicable standards and regulations. Partner closely with Operations, R&D, Regulatory Affairs, and Commercial teams to support product development, manufacturing, and market launch activities. Build and scale quality systems to match the company's growth trajectory, including internal and external auditing, supplier quality management, and CAPA systems. Develop and mentor a growing quality and regulatory team, fostering a culture of quality throughout the organization. Contribute to the broader strategic direction of the company as part of the senior leadership team, providing input on expansion initiatives and operational scale-up. Serve as the main point of contact with regulatory bodies during inspections, audits, and certification processes. About You Minimum of 10 years experience in Quality Assurance within the medical device industry, with at least 3 years in a leadership role. Deep knowledge of international medical device regulations and standards. Demonstrated ability to build, implement, and evolve scalable quality systems in a growing organization. Strategic thinker with strong leadership, communication, and team-building skills. Comfortable working in a fast-paced, entrepreneurial environment. Experience supporting product commercialization and operational expansion is highly desirable. Degree in Engineering, Science, or a related technical field; advanced degree preferred. Whats on Offer An opportunity to shape the future of a high-potential medical device start-up. A senior leadership role with influence across the entire organization. Competitive salary, equity participation, and comprehensive benefits package. A collaborative, ambitious environment with a leadership team known for successful start-up growth and exits. For further information please contact James Cassidy or call in conficence