Carlos Cruz

Quality Assurance Associate II

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Carlos is a Quality Assurance Associate II in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In his role, he is responsible for performing a variety of quality related tasks with a focus on supporting Quality Management System (QMS) improvements, data analysis, GMP activities, training, and perform investigations.

Prior to joining the ORAQ Team, Carlos worked at various medical device companies where he was responsible for QMS compliance, Management Review, Quality System Review Board, Material Review Board, Project Management, Global QMS Harmonization, internal audits Program Management, auditor trainer, external audit readiness, KPI development, CAPA / NC / Deviation SME, CAPA trainer, process validations, component qualification, product remediation, risk management files, supplier qualification, worksheet validation, calibration management, design verification, design validation, shelf life testing, biocompatibility protocols, and general quality support (e.g., 510K submissions, data analysis, DHR/DMR review and approval, vendor audits, etc.).   

Carlos received his bachelor’s degree in Industrial Engineering from the University of Rhode Island, Master’s degree in Quality Management Systems, Certified Lead Auditor ISO 13485:2016 & MDSAP, etc. When not working, Carlos enjoys spending time with family and friends, reading, and working at the farm.