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 company’s 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.

• 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.

• 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.