Senior Quality Director Opportunity
This is a leadership role within a dynamic medical device organization that requires strategic planning and implementation of quality systems, ensuring regulatory compliance, and promoting operational excellence as the business expands domestically and internationally.
About the Role:
* Develop and execute a comprehensive Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR 820, MDR, and other relevant standards and regulations.
* Collaborate closely with cross-functional teams to support product development, manufacturing, and market launch activities.
* Build scalable quality systems to match the company's growth trajectory, including internal and external auditing, supplier quality management, and CAPA systems.
* Mentor and develop a growing quality and regulatory team, fostering a culture of quality throughout the organization.
* Contribute to the company's broader strategic direction as part of the senior leadership team, providing input on expansion initiatives and operational scale-up.
Key Requirements:
* A 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.
* Strong leadership, communication, and team-building skills.
* Comfortable working in a fast-paced, entrepreneurial environment.
About What We Offer
A competitive salary, equity participation, and comprehensive benefits package are just some of the rewards for this exciting opportunity to shape the future of a high-potential medical device start-up. Join a collaborative, ambitious environment with a leadership team known for successful start-up growth and exits.