Sadhana Asokaraj

Engineering professional with 9+ years of experience in the medical device industry, focused on quality systems, risk management, and cross-functional process improvements. Expertise includes CAPA, nonconformance investigations, internal audits, ISO 14971 risk analysis, validation strategy, and regulatory compliance. Demonstrated success supporting Class III medical devices and neuromodulation therapies in FDA- and ISO-regulated environments. Known for driving detailed root cause analysis, improving batch release and complaint handling procedures, and standardizing documentation across multiple manufacturing sites. Skilled in cross-functional collaboration between design, manufacturing, and quality teams to enhance compliance, strengthen systems, and support site-wide initiatives. Currently building toward a transition into engineering program management, leveraging technical depth, process orientation, and a continuous improvement mindset to contribute to large-scale program success.