Senior Quality Engineer
Tom Soucie joined HepQuant as Senior Quality Engineer in March 2023. In this role Mr. Soucie is responsible for managing HepQuant’s robust Quality Management System (QMS) processes and methods, and for ensuring alignment with applicable FDA, QSR, CAP/CLIA and ISO 13485 requirements.
Backed by a wealth of expertise and credentials in quality management systems, including ISO 9001/13485/14971, GxP, 21 CFR, and SOR/98-282, and experience with security software and software validation, he most recently served in contractor engineering roles for LightDeck Diagnostics, Rook Quality Systems, and 3D Systems. In his role as Quality Engineer Contractor at Rook Quality Systems, he supported the design, development and sustaining engineering activities for various medical device clients, including support of an Investigational Device Exemption (IDE) application.
Previously, Mr. Soucie served as Senior Quality Engineer at LivaNova PLC, a global medical technology and innovation company, where he was responsible for equipment and disposable product complaints for all US LivaNova customers, primarily Class 3 devices. His background includes earlier roles at Syncardia, Ping Identity, Baxter Medical, Sandoz Pharmaceutical and BD Medical-Pharmaceutical Systems, where responsibilities centered on systems and product quality, including an emphasis on Corrective and Preventive Actions (CAPA).
A graduate of the University of Nebraska-Lincoln where he earned a Bachelor of Science degree in Industrial Engineering, Mr. Soucie also studied Backend Engineering at the Turing School of Software and Design in Denver and was a Certified ScrumMaster® through the Scrum Alliance organization.