Quality Leadership Role in Medical Device Sector
About the Opportunity:
We are seeking a Quality Director with strategic vision and leadership capabilities to join our executive team. This pivotal role involves shaping and executing our quality strategy, overseeing regulatory compliance, and driving operational excellence as we grow domestically and internationally.
Key Responsibilities:
* Lead the development and execution of our Quality Management System (QMS), ensuring 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 our broader strategic direction 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:
* A chance to shape the future of a high-potential medical device start-up.
* A senior leadership role with influence across the entire organization.
* Competitive benefits package.
* A collaborative, ambitious environment with a leadership team known for successful start-up growth and exits.