As Senior Manager of Quality Affairs, Sarah Downing is tasked with proactively managing HepQuant’s quality management system (QMS) processes and methods in alignment with all relevant regulatory and lab quality requirements.
Ms. Downing joined HepQuant in October 2018 with more than 14 years of experience in the regulated medical device industry where her attention centered on the quality aspects of systems, design and development, and process controls. Most recently she served as Principal Quality Engineer at Precision Biopsy, where she collaborated with various internal teams to create and manage the Design History File (DHF) for submission of a Class II, de novo device. In this role, she was also responsible for segments of the Quality Manual regarding updating procedures, supporting documents, managing activities, and ensuring compliance.
Prior to Precision Biopsy, Ms. Downing spent 10 years in Quality Systems and Quality Engineer roles at Baxa Corporation / Baxter Healthcare in Englewood, Colorado, most recently serving as a Lead Principal Quality Engineer and Product Design Owner for the Product Development Team. She began her career as a Quality Systems Specialist for Class III Implantable Medical Devices at Dentsply.
Ms. Downing holds a ASQ Quality Engineer Certification and is the author of a 2012 “Editor’s Pick” ASQ article on medical devices. She earned a Bachelor of Science degree in Engineering with Mechanical Specialty from Colorado School of Mines (CSM). She also minored in Biomedical Engineering at CSM.