Dr. Wayne Taylor - Taylor Enterprises, Inc.
for Engineers and Quality
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Dr. Taylor is a leading expert on the application of Statistics to the Medical Device and other FDA regulated industries. His new book Statistical Procedure for the Medical Device Industry sets the standard for applying statistics in compliance with Section §820.250, Statistical Techniques of the Code of Federal Regulations.
He is the founder and chairman of Taylor Enterprises, Inc. where he is responsible for the development of the VarTran®, Change-Point Analyzer, Sampling Plan Analyzer and Distribution Analyzer software packages as well as providing consulting and training on Statistics and the Six Sigma approach and tools including Robust Design, Tolerance Analysis, Design of Experiments, SPC and Acceptance Sampling.
In 2000, Dr. Taylor retired from his position as Director of Quality Technologies at Baxter Healthcare Corporation where he was responsible for Baxter's Six Sigma program. He and his staff have trained over 800 of Baxters engineers to serve as Six Sigma black belts. He had been with Baxter for 22 years.
He is also author of the books Optimization and Variation Reduction in Quality and Guide to Acceptance Sampling. The first book outlines the approach implemented at Baxter for achieving six sigma quality. The second book outlines a simple to use approach for selecting and justifying sampling plans as well as reducing inspection costs that is used throughout the medical device industries. This system has saved Baxter over 30 million dollars annually.
Dr. Taylor is the leading expert on acceptance sampling in the pharmaceutical, medical device and diagnostics industries. His articles on selecting statistically valid sampling plans have become standards in the industry and are used by the FDA in their new inspector training. He has taught his 2-day course Successful Acceptance Sampling to over 5,000 students and 50 companies including the CDRH (Center for Devices and Radiological Health) of the FDA.
Dr. Taylor is also a leading expert in Process Validation. He is author of Annex A of the Global Harmonization Task Force guideline titled Process Validation Guidance for Process Validation Engineers.
The VarTran software and Dr. Taylor's course Robust Tolerance Analysis have rapidly become a key component of many companies DFSS (Design for Six Sigma) programs. Honeywell, the Six Sigma Academy and numerous other companies have adopted VarTran as an essential tool for designing high quality products.
He has made many key contributions to the field of Quality including Variation Transmission Analysis, Process Tolerances, Quick Switching Systems and Change-Point Analysis. He has dozens of articles and hundreds of presentations to his credit.
Dr. Taylor received his Ph.D. in Statistics from Purdue University. He is a fellow of the American Society for Quality as well as a member of the American Statistical Association where he is an Accredited Professional Statistician™.
1996 - Elected a Fellow of the American Society for Quality
2008 – Recognized as one of 100 Notable People in the Medical Device Industry by MD&DI Magazine (alphabetical, Wayne Taylor is near bottom of page)
In this issue, MD&DI honors some of the people who make these advances
possible and who ensure that those devices can treat patients safely and
effectively. If we tried to list everyone who has made a significant
contribution to medical technology, we would have to publish an issue
larger than a phone book. So we are highlighting 100 of them on the
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Last modified: September 08, 2017