Alonso Mendoza (Cmq/Oe, Cqe,Cssgb,Cssbb,MBA)
About Alonso Mendoza (Cmq/Oe, Cqe,Cssgb,Cssbb,MBA)
Alonso Mendoza is a Senior Manager of Quality Engineering at Outset Medical, Inc., where he has worked since 2021. He has extensive experience in quality management and engineering, with previous roles at Cardinal Health and Magna Powertrain, and holds an MBA in Quality and Productivity.
Work at Outset Medical
Alonso Mendoza serves as the Senior Manager of Quality Engineering at Outset Medical, Inc. since 2021. In this role, he is responsible for overseeing quality engineering processes within the organization, focusing on enhancing product performance and compliance with regulatory standards. His leadership contributes to the improvement of key quality metrics, ensuring that the company meets industry expectations in the highly regulated hemodialysis sector. Mendoza leads various teams, including calibration engineering and OPEX-QA, to maintain high standards of quality management.
Previous Experience at Cardinal Health
Prior to his current role, Alonso Mendoza held multiple positions at Cardinal Health. He worked as a Senior Manufacturing Engineer for nine months in 2014, followed by a five-year tenure as QA Operations Superintendent from 2014 to 2019. He later served as Quality Operations Manager for one year from 2019 to 2020. During his time at Cardinal Health, he was instrumental in managing quality operations and implementing strategies that led to significant improvements in product performance.
Education and Expertise
Alonso Mendoza earned his Industrial Engineer degree in Manufacturing Engineering from Universidad Autónoma de Nuevo León, completing his studies from 2007 to 2011. He further advanced his education by obtaining a Master of Business Administration (MBA) in Quality and Productivity from Universidad Tecmilenio, which he completed in 2018. Mendoza possesses extensive knowledge in Quality Management Systems, particularly under ISO13485:2016 and FDA regulations, equipping him with the skills necessary for effective quality engineering.
Regulatory Activities and Certifications
Alonso Mendoza actively participates in regulatory activities, including Quality Management System (QMS) audits with official regulatory bodies. He has hosted audits from agencies such as TUV and ANVISA, contributing to the achievement of MDSAP certification. His expertise includes conducting risk evaluations on critical projects and ensuring compliance with regulatory standards, which is essential for maintaining product reliability and safety in the medical device industry.
Continuous Improvement and Strategic Planning
Mendoza has a strong background in continuous improvement and strategic planning. He focuses on exceeding customer expectations through the enhancement of product reliability and regulatory compliance. His experience includes leading initiatives that drive year-over-year improvements in key quality metrics, demonstrating his commitment to quality excellence in the organizations he has worked with.