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Director of Quality

SAN DIEGO

Boris Gurevich, ASQ CSQE & CQA, has over 20 years of experience in medical device quality, regulatory and IT compliance. Boris is both certified as a software quality engineer and quality auditor by American Society of Quality. In addition, he led the effort for BeanStock Ventures to become one of the FDA’s third-party certified reviewers (one out of nine worldwide) of regulatory submissions for Class II devices known as 510(k). Boris holds the position of Product Specialist for the Beanstock Ventures 3P510(k) program, coordinating the 510(k) reviews and providing BSV recommendation to the FDA whether device is cleared to be marketed in the US.

Boris’ extensive career in Quality includes supporting many quality audits (including FDA, BSI, MDSAP, client, supplier and internal) for companies such as Illumina and CareFusion. He led or held key roles in numerous quality initiatives, regulatory submissions and in the release of medical device products, as well as quality system software. Additionally, Boris is one of the three experts involved in the development of the BeanStock Ventures Software Online Agile Reporting (SOAR®) Training.

Boris Gurevich’s passion is in delivering innovative and high-quality products in order to support both product development and operations. Boris is focused on developing and growing an effective and scalable Quality Management System to help streamlining product and service delivery to BeanStock Ventures clients.

His quality journey began in business school with introduction to the principles of Total Quality Management. Boris received his MBA degree from Ben Gurion University in Israel.

Outside of the office, Boris enjoys traveling the world with his family and attending cultural events and music festivals.

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