Quality Director Position
About the Role
We are seeking a seasoned Quality Director to join our executive team and drive quality excellence in our rapidly growing medical device start-up. As a strategic leader, you will develop and implement our Quality Management System (QMS), ensuring compliance with international regulations such as ISO 13485, FDA 21 CFR 820, and MDR.
Key Responsibilities:
* Develop and execute the company's QMS, incorporating industry standards and best practices.
* Collaborate 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.
* Mentor and develop a high-performing quality and regulatory team, fostering a culture of quality throughout the organization.
* Provide strategic input on expansion initiatives and operational scale-up as part of the senior leadership team.
* Serve as the main point of contact with regulatory bodies during inspections, audits, and certification processes.
Requirements:
* Minimum of 10 years' experience in Quality Assurance within the medical device industry, with at least 3 years in a leadership role.
* Demonstrated expertise in international medical device regulations and standards.
* Proven ability to build, implement, and evolve scalable quality systems in a fast-paced environment.
* Strategic thinker with strong leadership, communication, and team-building skills.
* Experience supporting product commercialization and operational expansion is highly desirable.
* Degree in Engineering, Science, or a related technical field; advanced degree preferred.
What We Offer:
* A unique opportunity to shape the future of a high-potential medical device start-up.
* A senior leadership role with influence across the entire organization.
* Competitive compensation package, equity participation, and comprehensive benefits.
* A collaborative, ambitious environment with a leadership team known for successful start-up growth and exits.