Kelly comes to Pacific Diabetes Technologies with over 20 years of Quality Assurance experience, 12 years of which has been in the medical device field. Prior to joining PDT, she worked in Sensor Development and Quality Systems for a glucose sensor start up (iSense/Bayer Healthcare) for 4 years, and 8 years as Quality Manager for a medical device contract manufacturer and ETO Sterilization company (Dravon Medical Inc.). As a Certified Quality Auditor (ISO 13485:2016), she has lead auditor experience in FDA, Registered Body, Customer, Supplier, and Internal Audits. She has designed new Quality Management Systems and successfully brought aging QMS up to current standards and practices. Her goal is to develop robust quality systems that will build a framework for continuous improvement and bring PDT into ISO 13485 compliance.