Miguel Hernández
Supplier Quality Compliance Engineer @BEPC Inc. - Business Excellence Professional Consulting
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WORK HISTORY
Supplier Quality Compliance Engineer @BEPC Inc. - Business Excellence Professional Consulting
Lead medical device supplier audits response ensuring compliance with cGMP, ISO, and FDA regulations, while supporting client compliance program development.Analyzed audit findings to identify and mitigate compliance risks, ensuring timely updates to quality records and continuous inspection readiness.Drove supplier compliance improvement through proactive engagement, managing corrective actions, preventive actions and effectiveness monitoring plans.Implemented process improvements for SOPs and systems to mitigate risk and cultivate a strong quality culture.Prepared and presented comprehensive technical audit reports, including nonconformance observations and data analysis.Provided scientific and technical guidance to suppliers and customers on audit results and FDA compliance.Ensured full compliance with all federal, state, local, and company regulations, policies, and procedures
EDUCATION
CETYS Universidad
Engineer's degree, Ingeniería industrial
Universidad Internacional de La Rioja
Master of Business Administration - MBA, Master in Business Intelligence, Advanced Data Visualization, Predictive Analytics, and Big Data
ABOUT MIGUEL HERNÁNDEZ
Strategic Quality Leader with 15+ years of experience in the MedTech industry (Medtronic, Jabil Healthcare, Carl Zeiss, J&J). My career is driven by a passion for achieving superior quality standards through high-performing team leadership and a deep commitment to individual growth and mentorship.Team leader of talented engineers in the MedTech division of Jabil Healthcare, ensuring strict compliance for Class II medical devices under FDA, ISO 13485, ISO 9001, ANVISA, and COFEPRIS regulations. I specialize in bridging the gap between rigorous regulatory requirements and advanced Business Intelligence.I am pioneering the digital transformation of Quality Audit lifecycles by architecting executive-level dashboards that eliminate administrative waste and provide predictive insights. As a Subject Matter Expert (SME) for global audit systems, I am focused on evolving traditional Quality systems into Data-Driven Quality 4.0 ecosystems.My professional journey includes extensive experience in Vision Care manufacturing as part of global supplier quality teams, overseeing complex supply chains across North and South America, Asia, and Western Europe.
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