Anne Holland

Anne_2016Anne Holland combines more than 25 years of biomedical engineering with business acumen as founder and CEO of QA Consulting, Inc. Under her guidance, QA Consulting has grown from a local Austin-based firm, founded in 2000, to one of the leading HUB and WBENC-certified medical device consulting firms with clients throughout the nation. She is an expert in every phase of quality assurance from design concept and R&D through manufacturing/ production, and post-market surveillance for Class I, II, and III medical devices.

Anne’s expertise has been sought by medical device manufacturers, from startups to Fortune 500, to develop and implement compliant solutions that meet their quality and regulatory needs. She has been called as an expert witness on medical devices and regulatory compliance. Anne has conducted over 100 supply chain and internal audits. Clients rely on her thorough knowledge of good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory remediation. She facilitates and responds to FDA and ISO 13485 Notified Body audits for manufacturers.

Anne gained much of her knowledge of quality assurance and manufacturing operations during 15 years of working in the field. Prior to beginning her consulting business, she worked for Sulzer Carbomedics in Austin, TX; Ohmeda Monitoring in Louisville, CO; Cobe BCT, Inc., in Lakewood, CO; Fischer Imaging in Broomfield, CO; and LA BAC Medical Systems in Englewood, CO. She holds a B.S. in Biomedical Engineering from Vanderbilt University in Nashville, TN, and an MBA from the University of Colorado in Denver, CO.

Anne holds certifications as an ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Manager (CQM), RABQSA Quality System Lead Auditor, and Society of Quality Assurance Registered Quality Assurance Professional in Good Laboratory Practice.

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