Her Story
About Kamala
I have over 15 years in medical device quality and compliance, with a background in embedded system product development. I specialize in software and AI-enabled medical devices, ensuring compliance with FDA and European standards throughout development and release. As a subject matter expert, I implement quality management systems, mentor teams, speak at international conferences, and publish articles. I hold leadership positions in the American Society for Quality for over 10 years and contribute to AME standards for software and AI in medical devices. I am also an active STEM mentor and have led high school robotics teams.
Her Interview
Ten minutes with Kamala
01What advice would you give to young women entering your industry?
Ensuring quality and compliance is a crucial role that often faces pushback from development and cross-functional teams. One needs domain expertise and knowledge to explain requirements and lead effectively. Leadership skills and soft skills are essential, including staying calm and composed when challenged, while holding ground to prioritize patient safety. It is a continuous journey where actual learning happens by putting oneself in situations, but prior knowledge helps navigate better.
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