Mihir Adhikari
Quality Assurance Engineer @Nventric, Inc
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WORK HISTORY
Quality Assurance Engineer @Nventric, Inc
Arcadia, CA, US
Lead compliance efforts with ISO 13485 by managing employee training programs, approving material inspections, and maintaining regulatory documentation for manufacturing processes and devices-Conduct comprehensive risk assessments, including hazard analysis, DFMEA, PFMEA, and URRA, ensuring compliance with ISO 14971 for vascular devices-Manage equipment calibration schedules, ensure timely preventive maintenance, and verify supplier certifications to uphold quality standards and operational efficiency-Streamline processes by improving Document Control Orders, Lot History Records, and migrating training records to EQMS software (QCBD) for enhanced accuracy and efficiency-Support ISO 13485 audits by ensuring documentation accuracy, readiness, and alignment with regulatory requirements, contributing to successful outcomes.
EDUCATION
Dr.Vishwanath Karad MIT WORLD PEACE UNIVERSITY|PUNE
Bachelor of Technology - BTech
Johns Hopkins Whiting School of Engineering
Master of Science - MS
ABOUT MIHIR ADHIKARI
What I Do: Risk Management: Conduct DFMEA, PFMEA, hazard analysis, and URRA…
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