Provide technical support in areas including validation requirements, statistics, biocompatibility assessment, DFM, risk analysis, FMEA, root cause analysis, testing requirements and methods, quality equipment, specifications, vendor quality, among others, and coordinate with suppliers/vendors to review and mitigate any non-conformance product and hazardous situation. Lead the design, development and review of manufacturing process changes, product design improvements and the implementation of new products efforts with quality improvement opportunities for legacy products, continuous improvement, and customer satisfaction.