20+ years medical device industry experience, most of which has been as a "regular" employee in the medical device industry, at both start-up and established companies, where John worked in Manufacturing, Packaging, Process Engineering, Receiving QC, QC Lab, QA, Regulatory, and R&D.
10+ years in Quality/Regulatory, and 7+ years working part-time as a "Notified Body Auditor" to ISO 9001, ISO 13485, the Canadian MDR, and the EU MDD and IVDD.
Publisher of several commercial statistical application spreadsheets, of minimalist quality-system documentation & software suitable for lean start-up companies, and of HazMat65 (a commercial software application database for compliance with "Proposition 65", a.k.a. Prop 65 or Prop65).
Professional consultant, auditor, & trainer since 1999, with over four dozen clients, ranging from weeks-old startups to decades-old multinational companies. Primarily medical device companies, but some electronics and assembly industries.
John Zorich's references
John Zorich's general resume (one-page version)
(two-page version)
(four-page version)
John Zorich's statistics-related resume
John Zorich's Quality System Auditing Qualification & Training Records
W9 2008 for John Zorich