Leadership professional with several years of diverse experience in Medical Device Development and Manufacturing. Proven track record in production line scope, development, and validation from concept through production release. Experience working with all levels of an organization; R&D through manufacturing. Strong background in design controls, quality systems, data analysis/reporting, statistical methods, process improvement, CAPA, and root cause investigations at the facility, regional, and corporate levels using six sigma tools. Highly effective communicator with excellent interpersonal skills to foster successful relationships with internal cross functional teams