Barry Craner is vice president of quality assurance and regulatory affairs for Stellartech Research Corporation, a company engaged in contract manufacturing of durable and single-use medical devices. He also teaches risk management at the graduate level at two universities, the University of California–Santa Cruz and California State University–Dominguez Hills.
Craner has nearly 30 years of experience in the management of scientists and engineers in applications in medicine,aerospace, internet technologies and medical devices. He has written several design control systems for companies, and consulted in the areas of risk management, reliability engineering and quality system development. He has audited many medical device companies from first-, second- and third-party perspectives. He has earned advanced degrees in cardiac physiology and business management with a computer information systems emphasis with the equivalent of an electrical engineering minor.
Craner has delivered numerous papers and presentations since 1986 on topics such as calibration systems, management auditing, software quality assurance, risk management and managing contract design. He also teaches classes for the ASQ Silicon Valley section in risk management, design control and auditing. He was selected by the FDA as the sole industry representative to speak on “An Industry Perspective” at the FDA Pacific Region Centennial Celebration in 2006. He is an ASQ Fellow, RAC (RAPS), and past chair of the ASQ Biomedical Division and San Diego Section. He is an ASQ CRE, CQA, and CBA, and was on the founding team to create the body of knowledge and exam questions for the ASQ CQA-Biomedical Auditor certification program.