Sarah Downing Joins HepQuant as Senior Manager of Quality Affairs
Certified Quality Engineer Brings More than 14 Years Experience in Medical Device and Diagnostics Quality Affairs
DENVER (Nov. 15, 2018) — HepQuant, LLC, a Greenwood Village, Colo.-based company with a unique, patented and patent-pending technology for evaluating the liver in patients with chronic liver disease, today announced the addition of Sarah Downing as Senior Manager of Quality Affairs.
As Senior Manager of Quality Affairs, 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.
“Her credentials and experience in quality engineering for medical device companies make Sarah a welcome addition to the HepQuant Quality Team,” said Gregory T. Everson, MD, CEO and Chief Medical Officer of HepQuant.
Downing comes to HepQuant with more than 14 years of experience in the regulated medical device industry where her attention has 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.
“Besides her technical and organizational skills, Sarah possesses the ability to flourish in fast-paced environments,” observed Sean Bundy, Director of Regulatory & Quality Affairs. “In previous roles, she built a track record as a respected mentor and a highly collaborative team player. We look forward to a similar impact at HepQuant.”
Prior to Precision Biopsy, 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.
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.
Headquartered in Greenwood Village, Colorado, HepQuant, LLC, is a privately-held, early-stage combination drug and in-vitro diagnostic company. HepQuant’s products are investigational combination drug and in-vitro diagnostic devices and have not yet been evaluated or reviewed by the US Food and Drug Administration (FDA) for commercial sale. They are currently available for investigational use via the FDA IDE application process. For additional information, visit www.hepquant.com.
Tom Kennedy, Corporate Communications
firstname.lastname@example.org (720) 507-4164