Elizabeth Kempen joined Alquest in 2000 from Applied Biometrics, where she had served as Vice President of Quality, Regulatory and Clinical Affairs. She previously held management and staff positions with Bio-Vascular, Cardiac Pacemakers (Guidant), the University of Minnesota and INCSTAR. During her career, Elizabeth has established worldwide regulatory and clinical strategy and requirements definition for cardiovascular, interventional vascular, urological, biological, and IVD products. She also established quality documentation systems to meet US QSR, ISO 9001, EN 46001, ISO 13485, CMDCAS, European Medical Device and InVitro Diagnostic Directive requirements. She earned a B.S. degree from the University of Wisconsin in Microbiology/Public Health and a MBA from the Carlson School of Management at the University of Minnesota. |