Director of Quality | Medical Device

Medical Device Industry | Minneapolis–St. Paul, MN

Compensation: Approximately $200,000 total target cash compensation, including a 15% target bonus, plus equity eligibility.

Chase MedSearch has partnered with an innovative, privately held medical device company seeking an experienced Director of Quality / Senior Quality Manager to lead and further develop its corporate quality function.

About the Company:

Our client is an emerging medical technology company developing sophisticated Class III implantable medical devices designed to address significant unmet clinical needs. With an experienced leadership team and important clinical and regulatory milestones ahead, the organization is entering an exciting stage of development.

About the Role:

This is a highly visible, hands-on leadership opportunity for a quality professional who enjoys building and improving systems, working closely with senior executives, and making a meaningful impact within an entrepreneurial environment. The successful candidate will assume responsibility for the company's Quality Management System, lead key quality processes, and help establish the infrastructure necessary to support continued clinical development and organizational growth.

• Lead, maintain, and continuously improve the company's Quality Management System (QMS), ensuring compliance with applicable FDA regulations and ISO standards.
• Oversee Corrective and Preventive Action (CAPA) processes, including investigations, root cause analysis, corrective actions, and effectiveness verification.
• Manage complaint handling processes and ensure appropriate documentation, investigation, and resolution.
• Lead internal and external audits, including preparation, execution, corrective actions, and ongoing audit readiness.
• Oversee supplier quality management, including supplier qualification, monitoring, audits, and corrective action activities.
• Lead management reviews, quality metrics reporting, and continuous improvement initiatives.
• Evaluate and optimize existing electronic quality management systems and processes.
• Partner closely with engineering, R&D, operations, and executive leadership to integrate quality requirements into product development and business operations.
• Support quality system readiness for upcoming clinical and regulatory milestones, including activities associated with Class III implantable medical device development.
• Provide leadership, mentorship, and development to existing quality personnel.
• Develop scalable, practical quality processes that support both regulatory compliance and business objectives.

What You Need:

• Bachelor's degree in engineering, life sciences, or a related technical discipline.
• Significant progressive experience in medical device Quality Assurance, Quality Systems, or Quality Engineering.
• Strong knowledge of FDA medical device quality regulations and ISO 13485.
• Demonstrated hands-on experience with CAPA, complaint handling, audits, supplier quality, and QMS development or improvement.
• Experience working within a smaller medical device organization or entrepreneurial environment.
• Ability to independently evaluate quality systems, identify opportunities for improvement.