Carlos Mozo

Sr Design Quality Manager, R & d @Beckman Coulter Diagnostics

Miami, TX, US

Hire, develop and retain Sr. Staff/Staff level engineers and scientists in or order to maintain a highly engaged and technically proficient team in terms of design controls, document controls, risk management and general quality and regulatory compliance.• Manage and assess departmental and individual performance of its members by generating and implementing employee development plans.• Provide strategic direction for new product development and design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, risk management and post market quality assurance.• Represent Hematology and UA Business Units at the Corporate Design Controls Council (Design Controls Local Process Owner). Responsible for the update and optimization of Global Design Controls procedures.• Support FDA/Regulatory audits Back Room operations. Review documentation for adequacy and completeness. Provide guidance to SMEs facing the auditor.• Conduct Supplier Quality audit for OEM manufacturers/developers associated with the Hematology Analyzers platform to determine the adequacy of the OEMs quality system and alignment with FDA QSR, ISO, and other global regulations.• Quality Lead for NPD Hematology programs (Instruments, Reagents and Software).

D.I. Mendeleyev University of Chemical Technology, Moscow, Russia

MS, Chemical Engineering, Polymer/Plastics Engineering