James Ashby

James Ashby has over 20 years of experience in the quality assurance and regulatory affairs industry. James began their career in 1998 as a Field Assurance Coordinator and Document Control Specialist at Vasca Inc. In 2001, they became a Quality Assurance Specialist at LeMaitre Vascular Inc., where they managed and developed the company quality and regulatory systems to conform to ISO 9001 and GMP regulations, submitted 510(k)s for new product lines, and authored validation protocols for ETO and Gamma sterilization. In 2003, they became a Quality Engineer at Amersham Biosciences. In 2004, they joined Allen Medical Systems as a QA Supervisor and QA Compliance Specialist. In 2008, they moved to Hill-Rom as a Director of QA/RA and Manager QA/RA. In 2011, they became the Director of Quality Assurance at Enzymatics. Since 2015, they have been the Director of Quality Assurance at ArcherDX.

James Ashby received their Bachelor's degree in Political Science and Government from the University of Colorado Boulder in 1998, having started their studies there in 1994.