About Wayne "Aaron" Snyder

Aaron Snyder is the owner and lead consultant of Quality Systems Explained LLC where he helps his clients resolve their QMS challenges.  His most recent client work involved preparing a major IVD manufacturing site in Europe for an FDA inspection where he supported both process and software validation activities.

Previously, Aaron was the Vice President of Quality Assurance at Allotex, a Boston Massachusetts based biotechnology company working with human cornea tissue to address presbyopia and myopia.

Prior to Allotex, he worked at Fresenius-Kabi, Molnlycke Healthcare, Waters Corporation, Covidien, Cardinal Health, and General Electric in roles of increasing responsibilities.  Aaron has worked with a wide range of medical devices from simple class I disposable medical devices up to advanced class III surgical instruments, sterile IV drugs, aseptically compounded sterile drugs, and human tissue products.  He has over 21 years of medical device manufacturing experience which includes 15 years managing quality teams.

He is an experienced trainer that has led more than 60 training workshops across the following quality areas: 21 CFR 820 / ISO 13485, process validation, CAPA, 510K, and quality auditor.  He has trained over 800 FDA employees and more than 1400 industry professionals.  He is an expert in biotechnology quality management systems and an experienced quality assurance executive.

He has the following current American Society of Quality (ASQ) certifications: Six Sigma Black Belt (SSBB), Quality Engineer (CQE), and Software Quality Engineer (CSQE).  He is an Exemplar certified Lead Auditor for ISO 9001 and 13485.  He has received two advanced communicator gold awards from Toastmasters International.  He has presented hundreds of toastmaster speeches and also won the 2009 District 31 humorous speech contest.

Aaron earned two Bachelors of Science degrees from Purdue University in Mathematics and Industrial Management respectively.  He also earned the Northeastern University Master of Science in Regulatory Affairs degree.