Donna Callery
Donna Callery
Donna has >25 years of global industry experience in the medical device and pharmaceutical industry, with a focus on Quality Management System implementation and oversight. Donna joined Oligo Factory in April 2023 from Medtronic where she served as Principal Quality Supplier Engineer qualifying and overseeing contract manufacturers and OEMs for the North and South American markets across multiple business units.
Prior to Medtronic, Donna was the Director of Quality Assurance at Quanterix, a Medical Device company, where she built a team of 5 Quality professionals, implemented a validated electronic document system and led the company wide implementation of an ISO13485 Quality Management System. Additionally, Donna served as a Quality Director for AmericanBio, a CDMO that provides diagnostic reagents and medical device test kits in compliance with ISO9001, ISO13485 and cGMP regulations. She started her career at Seracare (formerly Boston Biomedica), where she held roles in Manufacturing, Quality Assurance and as Quality Assurance Manager.
Donna holds a Bachelor of Science in Biology and Chemistry from Stonehill College.
