Ann Quinlan-Smith joined Alquest in 1998 after serving as Vice President, Regulatory and Clinical Affairs/QA for MICROVENA, Inc. Ann previously held clinical, regulatory and marketing positions with Cardiac Pacemakers (Guidant), American Medical Systems and Kallestad Diagnostics. During her career, Ann established worldwide regulatory and clinical strategy and requirements definition for cardiovascular , interventional vascular, urological and IVD products. She also established quality documentation systems to meet US QSR, ISO 9001 and European Medical Device Directive requirements. Ann’s credits include clearance/approval of numerous submissions including premarket notifications. Ann earned a B.S. degree in medical technology from the College of St. Benedict in Minnesota, and an MBA from the Carlson School of Management at the University of Minnesota. |