Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes • Demonstrated expertise to effectively communicate within all levels of the organization around concepts of Repair/services controls, Repair/services verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc. DMIAC, SPC, Lean SS, 5S, 8D) • Experience leading and implementing change • Experience performing internal and external audits • Exceptional analytical, problem solving & root-cause analysis skills • Ability to multi-task & handle tasks with competing priorities effectively • Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.