Sai Ranjith Ramakrishnan Kumar is a quality engineering lead at Sanofi, specializing in software as a medical device (SaMD), AI enabled medical device quality systems, and regulatory compliance across ISO 13485, IEC 62304, ISO 14971, and 21 CFR 820. With more than eight years of experience at leading medical device companies including Smith & Nephew and SpectraWave Medical, Ranjith has led quality engineering in multiple 510(k) and PMA programs, including the first AI-integrated medical device frameworks. He serves as programs chair for the ASQ Granite State Section and sits on editorial review boards for ASQ Lean Six Sigma Review (LSSR) and Quality Management Forum (QMF), peer-reviewing white papers and manuscripts. He holds ASQ Six Sigma Green Belt certification and is recognized as an expert in bridging traditional device quality frameworks with emerging AI/ML technologies. Ranjith is a published author and speaker whose work has appeared in Quality Magazine, ASQ Quality Progress, and Bonezone Magazine, and who has presented on AI-enabled medical device quality at industry conferences.