Janet Book

Janet Book

Medical Devices Consultant

Medical Devices and IVDs

North America

Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices, with both large and small companies.

Janet has conducted internal and supplier audits utilizing many different industry-specific standards. She has also conducted due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars.

Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University, teaching quality concepts as part of its Master of Science in Biotechnology and Management (MSBM) program. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in the world of privacy by providing guidance with regard to quality, regulatory and compliance functions. Janet is also a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.

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