Fantu Leka serves as the Director of Quality at Baxter International Inc., where he leverages over 25 years of extensive experience in quality management within the FDA-regulated medical device industry. His role is pivotal in ensuring that all quality functions—ranging from Quality Operations and Quality...
Fantu Leka serves as the Director of Quality at Baxter International Inc., where he leverages over 25 years of extensive experience in quality management within the FDA-regulated medical device industry. His role is pivotal in ensuring that all quality functions—ranging from Quality Operations and Quality Engineering to Supplier Quality and Compliance—are executed with the highest standards. Fantu's expertise in ISO 13485, design control, and validation processes underpins his leadership, allowing him to effectively oversee equipment and process validations critical to maintaining regulatory compliance and product integrity.
One of Fantu's key projects involves enhancing the global supplier quality management system, where he applies his Six Sigma Black Belt certification and statistical applications to optimize supplier controls and risk management strategies. His deep understanding of CAPA processes and 21 CFR Part 11 compliance ensures that Baxter not only meets but exceeds regulatory expectations, fostering a culture of continuous improvement. Fantu’s proficiency in the DMAIC methodology has been instrumental in driving process enhancements that lead to increased efficiency and reduced variability in manufacturing.
As a management representative for the site, Fantu plays a crucial role in bridging communication between various departments and stakeholders, ensuring that quality remains a top priority throughout the organization. His strong background in change control and validation processes positions him as a trusted leader in navigating the complexities of the medical device landscape, ultimately contributing to Baxter's mission of delivering safe and effective healthcare solutions.
