Kate Bartelli serves as Vice President of Quality and Regulatory at Forj Medical. Bartelli brings more than two decades of experience in quality and regulatory leadership within the medical device and life sciences industries. She oversees the company’s global quality strategy, quality management systems, and regulatory compliance, working with teams across the organization to support operational excellence and ensure compliance across Forj Medical’s global operations.
Prior to joining Forj Medical, Bartelli served as Vice President of Quality and Regulatory at Trelleborg Medical Solutions, where she led global quality and regulatory initiatives. Throughout her career, Bartelli has built and strengthened global quality management systems and worked across international markets. Her expertise includes ISO, FDA QMSR, EU MDR, and other quality and regulatory standards, as well as developing relationships with notified bodies and regulatory organizations to support compliant quality systems and successful audits.
Bartelli holds an MBA from the Carlson School of Management at the University of Minnesota and a B.S. from the University of Minnesota. She is also a Certified Lead Quality Auditor through the American Society for Quality.