Sandeep Jangiti
Director of Quality - Global @Nyxoah
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WORK HISTORY
Director of Quality - Global @Nyxoah
Atlanta, GA, US
Reported directly to the CEO, overseeing the scaling of the global Quality organization during a high-stakes commercialization phase.Spearheaded the QMS transformation to align with FDA QMSR and ISO 13485 standards, successfully transitioning core operations to the U.S. to facilitate market launch.Played a pivotal role in securing FDA PMA approval and led the organization through a successful DEKRA recertification, maintaining ISO 13485 compliance for a new 3-year cycle.Directed cross-functional initiatives across Quality, Operations, and Regulatory to modernize CAPA systems, supplier oversight, and global inspection readiness.
EDUCATION
University of North Florida
MSEE, Electrical & Computers Engineering
Jawaharlal Nehru Technological University
Bachelors, Electrical Engineering
University of Florida - Warrington College of Business
Master of Business Administration (MBA), International Marketing and Finance
SKILLS
ABOUT SANDEEP JANGITI
Strategic Quality leader with 15+ years of experience driving CAPA excellence, QMS optimization, and FDA inspection readiness within Class implantable and complex medical device environments. Expert in aligning global systems to ISO 13485, FDA 21 CFR 820, and forthcoming QMSR expectations. Proven success transforming CAPA effectiveness, harmonizing global QMS frameworks, and achieving flawless FDA, TUV SUD and DEKRA outcomes through data-driven leadership and cross-functional collaboration.
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