John Nicholas Zorich Jr., MS, CQE John's career began with 20 years medical device industry experience, as a "regular" employee at both small start-up and large established companies. During those years, John worked in a variety of departments, including R&D, Manufacturing, Packaging, Process Engineering, Receiving QC, QC Lab, and QA/Regulatory. In 1999, he began full-time consulting in quality systems, regulatory compliance, and statistical methods. From 2000 to 2013, he worked over 50% time as a subcontracted "Notified Body Auditor", first for TUV and then for KEMA/DEKRA. Since 2014, he's worked solely as a statistical consultant & trainer. As a statistical consultant since 1999, his client list ranges from weeks-old startups to decades-old multinational companies, primarily in the medical device industry. He also is designer and publisher of several widely-used commercial formally-validated statistical application spreadsheets.