Mario Monge is a seasoned professional in the field of microbiology, boasting over 20 years of experience, with a significant 14 years dedicated to multinational corporations. As the Director of Quality at ICU Medical, he plays a pivotal role in overseeing the Quality Management System...
Mario Monge is a seasoned professional in the field of microbiology, boasting over 20 years of experience, with a significant 14 years dedicated to multinational corporations. As the Director of Quality at ICU Medical, he plays a pivotal role in overseeing the Quality Management System (QMS) for the entire operation. His extensive expertise in quality systems, validation processes, and industrial microbiology positions him as a key leader in ensuring compliance with stringent regulatory standards.
In his current role, Mario is responsible for the planning, organization, control, and evaluation of the QMS, ensuring that all operational aspects align with the highest quality standards. He adeptly manages the department's budget, demonstrating his strong project management skills and financial acumen. One of his notable achievements includes leading the organization to successfully attain ISO 13485:2016 certification, a testament to his strategic vision and execution capabilities. This involved defining and implementing a comprehensive plan that not only met regulatory requirements but also fostered a culture of continuous improvement and operational excellence.
Mario's proficiency in tools such as Minitab for statistical analysis, along with his certification as a Certified Quality Engineer (CQE) by ASQ and his experience as a Lead Auditor for Quality Systems, further enhance his ability to drive quality initiatives. His strong leadership skills enable him to effectively guide multidisciplinary teams, ensuring that all members are aligned with the organization's quality objectives. With a keen focus on risk management and regulatory affairs, Mario Monge continues to be a driving force in advancing quality standards at ICU Medical, ultimately contributing to the delivery of safe and effective medical products.
