Jay Maki has extensive experience in quality control and regulatory affairs. Jay started their career at NSM as a Quality Manager from 1987 to 1996. Jay then served as a Senior Quality Engineer at Tapemark Company from 1997 to 2006. Jay then joined Brady Medical - TruMed Technologies as a Quality/Regulatory Affairs Manager from 2006 to 2007. Currently, they are working at ARKRAY USA as a Quality Control Manager since 2007. In this role, they are responsible for all Quality Control and Inspection activities, process validations, supervising QC staff, supporting investigations, participating in audits, and managing various projects related to quality and regulatory compliance. Jay is also involved in implementing ISO 13485:2016 and UDI (FDA 21 CFR Part 830) at ARKRAY USA.
Jay Maki has a Bachelor's degree in Industrial Technology with a minor in Business from Minnesota State University Moorhead. Additionally, they attended Moorhead High School, but no further details about their education history at this institution are provided.
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