Quality System Manager
February 2014 — Present
Responsible for managing the prioritization, development and execution of system validations to maintain the integrity of the Presource Quality Systems and ensure 21 CFR Part 11 compliance. Audit and identify regulatory risks within the systems used by the Presource kitting buisness. Accountable for managing prioritiazation and delivery of solutions to mitigate system risk. Responsible for leading within the Medical Segmetn upstream data processes to comply with UDI regulation.