Quality Leadership Role
We are seeking a Quality Director with strong strategic vision and leadership capabilities to drive quality excellence in our organization. This is a pivotal role where you will shape and execute the company's quality strategy, oversee regulatory compliance, and drive operational efficiency.
* Partner closely with cross-functional teams to support product development, manufacturing, and market launch activities.
* Build and scale quality systems to match the organization's growth trajectory including internal and external auditing, supplier quality management, and corrective action systems.
* Mentor and develop a growing quality and regulatory team fostering a culture of quality throughout the organization.
* Contribute to the broader strategic direction of the organization 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.
Requirements:
* 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.