Gaurav Patel
Sr Director of Quality Systems @ICU Medical
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WORK HISTORY
Sr Director of Quality Systems @ICU Medical
Responsible for Corporate Quality Systems including Management Controls, CAPA Program, Design Controls, Risk Management, Documentation and Training Systems, Quality Data Analytics and associated Quality IT applications across ICU Medical including Smiths Medical. Also responsible for various aspects of the continuous improvement integration efforts associated with Quality IT applications, QMS harmonization, P & PC and other projects related to the ICU Medical’s integration efforts including Smiths Medical. Leading an overall team of 40+ employees across multiple sites. Key responsibilities: • Implementation of a harmonized and standardized Quality System across all ICU Medical sites including Smiths Medical. • Lead harmonization of the ICU Medical QMS, while ensuring compliance with the US FDA Quality System Regulations (21CFR820, 210, 211), ISO 13485:2016, EU MDD/MDR, International Standards and other regulations as required. • Integration and standardization of Quality IT applications (Agile PLM, LMS – iLearning, Data Analytics and Business Intelligence, specific Oracle EBS initiatives) across all ICU Medical sites including Smiths Medical • Drive project management and integration of key Quality and Regulatory IT applications including system maintenance, enhancements, configuration and upgrades • Lead coordination efforts associated with other application implementation dependencies • Drive implementation and continuous improvement initiatives of the Quality System by developing and improving procedures, processes and providing training to ensure compliance requirements are being met at all sites • Drive implementation of harmonized quality metrics with focus on actionable intelligence and effective real time reporting capabilities. • Support Design Controls and Risk Management across ICU Medical by continually partnering with R&D, Sustaining Engineering, Mfg and Quality Engineering to improve product development and change control processes.
EDUCATION
Gujarat University
Bachelor of Engineering (BEng), Information Technology
New Jersey Institute of Technology
Master of Science (MS), Biomedical Engineering
SKILLS
ABOUT GAURAV PATEL
I am an experienced Quality Systems Management Professional (BSE, MSBE, 6SGB) with…
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