She has 10 years’ experience in medical biotech development, QA, and validation under FDA cGMP’s and ISO 9000 guidelines. At LifeScan, she tests software for the automated test and assembly stations on blood glucose meter manufacturing lines. As a V&V professional, her overriding goal is to bring a focus on quality, from requirements to test, for system development. To build in quality, an organization needs to find problems early in the development cycle. This minimizes the time and cost of a project. Biotechnology’s diverse engineering teams share their different quality assurance methods to achieve this goal; consequently, at LifeScan, Edith was introduced to Failure Mode and Effects Analyses (FMEA’s). Edith has a B.A. in computer science. She added QA laboratory work, electronics, and manufacturing statistics skills through work experience and further education.