QMS Consulting, Inc.

Quality Management Solutions

HomeSue Jacobs

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Sue Jacobs, Principal Consultant, specializes in US FDA compliance with medical device quality and regulatory requirements. Ms. Jacobs has more than 30 years experience in the medical device industry. She assists manufacturers and suppliers in developing compliant and sustainable quality systems. She has served as a quality system expert witness on behalf of the US Food and Drug Administration. She participated in FDA/Industry Grassroots Task Force meetings which implemented the program to pre-announce FDA inspections, annotate FDA Form 483s, and send close out letters after inspections. She also was a member of the Advisory Committee that wrote AdvaMed’s Points to Consider When Preparing for a QSIT Inspection. Ms. Jacobs developed AdvaMed MTLI's "CAPA, A New Direction" in collaboration with CDRH and Medtronic. Ms. Jacobs served on the Board of Directors for the American Society for Quality (ASQ) 2004-2006. Ms. Jacobs is a member of the Regulatory Affairs Professional Society (RAPS), faculty member for AAMI’s GMP and Industry Practice Course and frequent speaker at educational programs for AdvaMed MTLI, MD&M (Canon Communications) FOI Services, FDANews, Thompson Interactive, and Management Forum Ltd.

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Sue Jacobs

 
 
PROFESSIONAL EXPERIENCE
  • Founder and President of QMS Consulting, Inc., 
  • GMP expert witness on behalf of the US Food & Drug Administration
  • ASQ Board of Directors as National Director (2004-06) 
  • Contributing author "The Biomedical Quality Auditor Handbook", Published 2003
  • Chairman of the ASQ Biomedical Division (2002-2004), Program Chair 1997 - 2001 (RAPS)
  • GMP Requirements and Industry Practice Course Instructor - AAMI (Association for the Advancement of Medical Instrumentation)

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