Quality Director – Medical Device Start-Up
About Our Client
We are a dynamic, well-funded medical device start-up based in Galway, poised for significant growth as we move further into the operational space. Led by a highly experienced management team with a proven track record of success in the start-up ecosystem, our 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 our executive team. This is a pivotal role where you will shape and execute our company's quality strategy, oversee regulatory compliance, and drive operational excellence as we grow both domestically and internationally.
Key Responsibilities
* Lead the development and execution of our 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 our 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 our 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.
What's 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.