Cemil Utku Benli
Senior Manager, Quality Assurance @Heartflow
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WORK HISTORY
Senior Manager, Quality Assurance @Heartflow
Sunnyvale, CA, US
International medical technology company, revolutionizing precision heart care with a passion about transforming the diagnosis and management of coronary artery disease and continue to innovate using the power of AI algorithms, pushing into new frontiers and forging incredible partnerships along the way. • Led implementation of enterprise eQMS to modernize software documentation, traceability, and audit readiness across regulated medical software development.• Owned planning and execution of verification and validation activities supporting FDA 510(k) and EU MDR submissions for Advanced Deep Plaque Algorithms.• Partnered with engineering, regulatory, and clinical teams to ensure IEC 62304 and ISO 13485 compliance across the SDLC.
EDUCATION
Bentley University - McCallum Graduate School of Business
Master of Business Administration, Finance, General
Bilkent University
Bachelor of Science, Electrical and Electronics Engineering; Telecommunication and Networks
SKILLS
ABOUT CEMIL UTKU BENLI
Senior Software Quality Assurance Leader with +12 years of experience driving quality strategy for large-scale, regulated, and AI-powered platforms. Proven track record of building and leading autonomous QA and SDET teams, designing automation frameworks integrated into CI/CD pipelines, and supporting FDA 510(k), EU MDR, and SaMD compliance. Deep expertise in test strategy, risk-based testing, and shift-left quality for cloud-native and medical software systems. Exceptional knowledge in leading QA initiatives in Software as a Medical service (SaMD) field with great understanding of IEC 62304, 21 CFR Part 820 and ISO 13485.
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