Stephen Mundwiller, CQA, CQMgr, CQPA


Steve Mundwiller has provided comprehensive ISO consulting services, training and mentoring services, and systems development to manufacturing and service sectors, both public and private.

Key engagements include; ISO 9000 auditing and ISO consulting  for quality systems development, transition and audit preparation, Lean Manufacturing, Supply Chain Management and Improvement, Good Manufacturing Practices (GMP’s) systems development and improvement meeting the requirements of the U.S. Food and Drug Administration (FDA), leadership coaching and development, team development, mentoring and improvement, Statistical Process Control (SPC) training, Continuous Improvement, Kaizen, Benchmarking and general problem resolution.

Steve’s prior experience includes many years improving, developing, implementing, and auditing in the pharmaceutical, medical device industries.  Steve has trained hundreds of individuals at dozens of organizations in Good Manufacturing Practices, ISO 9000 and related systems, Statistical Process Control, Supply Chain Improvements, and general Quality Assurance.

His work experience includes Medical Device (Allied Health), Pharmaceuticals (Sherwood Medical, Mallinckrodt), Manufacturing (Reckitt Colman, Watlow Electric) and Chemical (Sigma Chemical).

His background includes:

  • BS Biology, University of Missouri, St. Louis.
  • RAB/QSA-certified Principal Auditor; IRCA Certified ISO 9000 Auditor / Lead Auditor.
  • American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified Manager of Quality/Operational Excellence (CMQ/OE), Certified Quality Process Analyst (CQPA), and Certified Six Sigma Green Belt (CSSGB).  ASQ St. Louis 1304  Past Chair.
  • Missouri Quality Award (MQA) Examiner (2006-2007)
  • Industry experience within FDA/ISO 13485 medical device, AS 9100 Aerospace, ISO 9001 manufacturing, ISO/TS 16949 Automotive, and FDA/GMP pharmaceuticals compliance.

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