John Zorich
Client List
Houston TX
Silicon Valley CA
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
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.

John Zorich's references

John Zorich's statistics resume

For records of John's Qualification and Training, see the bottom of this page.

John has written a few articles and booklets that may be of interest to you.
  • statistics-related articles can be found on the "Statistics" page on this website  
             (see link, in the red column to the left of here).
  • other articles are provided next here:


2019-08-01, Director of Regulatory & Quality at a US medical device company:
"I first met John thru one of his online webinars in which he discussed rationale for statistical sampling plans. John Specializes in
applied industrial statistics. As a small start-up medical device developer and manufacturer, he has filled our need to provide
expertise, input and justification for statistical methods and sampling plans. Our internal procedures have been updated based
upon his Statistics SOP, which helps to assure that we meet regulatory requirements for valid and justified plans. A perfect fit for
our needs!"

LINKEDIN Endorsements,  found at:
  •  53  for  Statistics
  •  48  for  SPC (Statistical Process Control)
  •  43  for  Data Analysis

John's training and qualification records are shown individually below.
To  download a copy of a given record listed below, mouse-click its name:

ASQ Quality Engineer Certificate (expiration 2020)

All of the following records are "quality system" related (not statistics related)
CMDCAS Training, 2000
CMDCAS Certification, 2000
CMDCAS Re-certification, 2004
CMDCAS Ongoing Certification thru KEMA(DEKRA)
KEMA(DEKRA)  Auditor Training 2003
KEMA(DEKRA)  Auditor Training 2004
KEMA(DEKRA)  Auditor Training 2005
KEMA(DEKRA)  CE+ISO_13485 Audit Training 2005
KEMA(DEKRA)  MDD Training 2008
KEMA(DEKRA)  ISO 9001:2008 Training 2009
KEMA(DEKRA)  ISO 13485:2003 Training 2010
KEMA(DEKRA)  Auditor Certificate (ISO 13485 and ISO 9001), 2010
KEMA(DEKRA)  ISO 13485:2003 Training 2011
KEMA(DEKRA)  training (on ISO 13485, ISO 17021, and GD211) 2012
KEMA(DEKRA) training (13485 and 17021) 2013
Lead Auditor Training (Stat-A-Matrix) 1993
TUV MDD Training, 2000
TUV Miscellaneous Training, 2000
TUV IVDD Training, 2001
TUV MDD Certificate, 2002

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