Kelsey Huston Email and Phone Number

2016-2017Part of a team that established post-sterile lot qualification for finished goods & investigated device failures. Created the validation plan & drove execution for the validation of Ocean Freight shipping of FG Product. Managed calibration/PM’s -restructured the equipment management portion of quality systemSupported UDI implementation by determining in-process inspections at the manufacturer and helping to resolve initial labeling issues2017-2018 (International Quality Engineer)Spent 50% of 2017 (2 months on 2 months off) in Shenzhen China supporting MFG quality and incoming inspection at the finished goods manufacturing site. Managed NCMRs and SCARs at the manufacturing site and reduced open SCARs by 50%. Provided technical & quality support for resolution of manufacturing issues at the manufacturer and component supplier. Supported validations to dual source the supply chain & worked on a cross-functional team to re-define/streamline qualification requirements for injection molded components, based on scientific molding processes.Created visual aids to align attribute inspection for all injection molded components between the manufacturer, component supplier, and Insulet.

• Adapted and created new test methods, SOPs, and test fixtures• Created a FMEA guidance document for spike plate shoes, which required use of Rhino, Illustrator, and critical thinking skills to define requirements. This document was presented to and accepted by the R&D team. • Performed mechanical testing such as tensile, flex, durometer, specific gravity and compression set