Abhilash Kathroju
Senior Design Quality Engineer @Advita Ortho
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WORK HISTORY
Senior Design Quality Engineer @Advita Ortho
Gainesville, FL, US
EDUCATION
University of Bridgeport
Master's degree, Mechanical Engineering
JNTUH College of Engineering Hyderabad
Bachelor's degree, Mechanical Engineering
ABOUT ABHILASH KATHROJU
Quality and Engineering professional with 8+ years of experience in the medical device industry, specializing in quality systems, regulatory compliance, and process improvements. ASQ Certified Quality Engineer with expertise in applying a wide range of quality tools, including risk management, CAPA, FMEA, root cause analysis, and statistical techniques to enhance product reliability and ensure compliance with global standards.Proficient in medical device regulations and standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR. Skilled in collaborating with cross-functional teams to drive continuous improvement, streamline manufacturing processes, and support product development from concept to commercialization.Passionate about advancing patient safety and product excellence through data-driven decision-making and innovative quality solutions. Always open to networking, sharing insights, and discussing best practices in medical device quality and engineering.
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