EAB Spotlight: John E. Lincoln
John E. Lincoln is principal of J. E. Lincoln and Associates (www.jelincoln.com), a consulting company with over 28 years experience including 16 years as a full-time consultant, serving US Food and Drug Administration-regulated industries. John has worked with start-up to Fortune 100 companies in the US, Canada, China, France, Germany, Mexico, Sweden, and Taiwan.
John specializes in medical device current good manufacturing practices, systems, and standard operating procedures; product to market, defect, and cycle time reduction; equipment, process, product, and software documentation; validation, quality and regulatory management; product risk and ISO 14971; product clearance and regulatory issues resolution. Mr. Lincoln has worked for such companies as Abbott Laboratories, Mallinckrodt Medical, Hospira, and Integra and has held assignments as vice president of research and development, director of quality assurance, senior quality assurance engineer, and senior manufacturing engineer. He has additional experience in civil and military government, aerospace, and electronics industries.
Mr. Lincoln has published numerous peer-reviewed articles on culture change, training, biohazards, quality, regulatory affairs, corrective action and preventative action, and validation. He conducts webinars, workshops, and training worldwide. He holds a Bachelor of Arts from the University of California-Los Angeles.
John can be contacted by e-mail at jel@jelincoln.com or by phone at 435.882.4655.
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