Glenn Mendoza currently serves as a Principal Quality Engineer at Medtronic, where he leverages over a decade of experience in quality assurance within regulated industries, particularly focusing on the biotechnology and pharmaceutical sectors. Since his promotion to this pivotal role in July 2019, Glenn has...
Glenn Mendoza currently serves as a Principal Quality Engineer at Medtronic, where he leverages over a decade of experience in quality assurance within regulated industries, particularly focusing on the biotechnology and pharmaceutical sectors. Since his promotion to this pivotal role in July 2019, Glenn has been instrumental in enhancing the quality systems that underpin Medtronic's commitment to delivering safe and effective medical devices. His extensive expertise in Good Manufacturing Practices (cGMPs) and regulatory compliance ensures that all products meet stringent industry standards, thereby safeguarding patient health and safety.
In his current position, Glenn leads key projects centered around Computer System Validation (CSV) and Quality Auditing, ensuring that automated systems and enterprise software adhere to 21 CFR Part 11 regulations. His adeptness in change control management has been crucial in streamlining processes and mitigating risks associated with product development and manufacturing. Glenn's role also involves conducting thorough validation reviews of laboratory systems and equipment, which are essential for maintaining the integrity of data and compliance with regulatory requirements.
Glenn's proficiency in Corrective and Preventive Actions (CAPA) further enhances his ability to identify and resolve quality issues proactively, fostering a culture of continuous improvement within the organization. His collaborative approach and strong communication skills enable him to work effectively with cross-functional teams, driving initiatives that not only meet regulatory demands but also align with Medtronic's mission to innovate and improve patient outcomes. As a thought leader in quality engineering, Glenn Mendoza exemplifies the dedication and expertise necessary to navigate the complexities of the medical device industry.
