Industrial Engineer with more than 14 years of background working in Quality Systems based on ISO 13485 and FDA regulations. With experience managing different areas of quality system such as, document control, internal and external audits, supplier controls.Experience hosting and coordinating notified body audits as well as customer audits; with wide background working with supplier quality programs, auditing suppliers, developing new suppliers base locally and out of the country. With knowledge on problem solving activities using quality improvement tools and statistical analysis during root cause investigations.Certified as Quality Auditor, ISO 13485 Lead Auditor , Risk and CAPA Manager; And, trainings on Lean Black Belt Methodology and Implementación of New EU's Medical Device regulation.
Listed skills include Supplier Quality, Problem Solving, Quality System, Quality Assurance, and 6 others.