
Stephanie McCollum
Consultant | Business Manager
stephanie@gsdmeddevice.com
Stephanie co-owns GSD Medical Device Consulting and has been its Business Manager and Consultant since it was founded in 2020. She also serves as Treasurer and Secretary. She runs the business side of the firm and supports clients in building and maintaining quality systems for medical devices.
Experience & Expertise
At GSD, Stephanie supports clients with:
Quality management systems: writing the standard operating procedures that make up a quality system, and handling the day-to-day processes in it: complaints, CAPA, nonconformances, training, document control, supplier management and purchasing.
Audits: as an ASQ Certified Quality Auditor, she takes part in internal audits, supplier audits and notified body audits.
Quality software: helping companies set up and move onto eQMS platforms, including Greenlight Guru, Qualio, Enlil and Propel.
Suppliers and supply chain: drawing on her experience as a Global Supply Chain Manager at Boston Scientific EP Technologies, she helps clients with supplier oversight, purchasing controls and component sourcing.
Background: Before GSD, Stephanie worked in supply chain and operations at Ford Motor Company, consulted at Ernst & Young on Lawson ERP rollouts (writing process documentation, test scripts and running integrated testing), and spent nearly ten years as Business Manager of a school and church. There she oversaw finance, HR, facilities and audits for a staff of 35. She holds an MBA in Finance from the University of Nevada, Reno and a BA in International Relations from UC Davis.
Contact
I'm always looking for new and exciting opportunities. Let's connect.
650-222-7248