Plan, develop, execution and release of Quality Planning and Management Review processes at Enterprise level. Maintenance and improvement of procedures and processes in collaboration with stakeholders across the organization to ensure compliance with policies, internal & external standards and regulations and functionality across different entities. Monitor KPIs performance for Enterprise Functions entity. Support internal & external audits. Continuos improvement of the processes.

SME as Quality Fuction in Cell Operating System transformation of 7 manufacturing workflows in a span of 2 yrs. Implementation of strong controls (no operator dependen) decreasing weak controls from 90 to 20% . Alignment of steps with new part numbers & photographs. Failure modes updates according to new controls established. Lead Quality Inspection High Maturity increasing a 30% of outcome in the same space.Correction of issues thru DMIAC: cost avoidance above $400K with a decrease of scrap in the final product due a lack of specification in the front manufacturing lines. Controlled Environment Validations.

Responsible of the quality inspection team. Document change control. Management of Risk documents and failures risks. Creation of virtual library of defects to improve operators training material and defect identification.

Execution of sterility test in finished goods heart valves. Bioburden test in pre steriles valves. Measurement of concentration of chemicals in solutions. Integrity filter test for solution systems.