Summary
Victor Chau is a Quality Manager with 12 years of experience specializing in medical device and biopharma quality systems, including 21 CFR Part 820, ISO 13485, and MDSAP audit closures. He has led site-wide validation planning, developed vigilance programs, and architected QMS e-documentation and testing strategies that bridge software validation with traditional QC lab operations. Victor has hands-on experience with CAPA, deviations, supplier audits, UDI requirements, and batch release decisions across regulated manufacturing environments. He also brings software engineering training and practical experience in QA-focused automation and testing from a General Assembly fellowship, enabling him to design robust validation scripts and QMS testing frameworks. Known for driving cross-functional initiatives—such as harmonizing customer notification portals and leading lab operations improvements—he pairs scientific rigor from a Biochemistry degree with pragmatic process and data-driven quality leadership. Based in Rockville, MD, he combines regulatory depth with a penchant for translating complex compliance needs into auditable, maintainable systems.
12 years of coding experience
4 years of employment as a software developer
Bachelor's degree Biochemistry, Bachelor's degree Biochemistry at Worcester Polytechnic Institute
Chinese, English