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Paul Area Consultant at Operations Consulting Medical Devices Education Universidad de Puerto Rico 1979 - 1980 None, Spanish University of California, Los Angeles 1973 - 1974 DNF, Diploma, Quality Control San Diego State University-California State University 1970 - 1972 DNF, MS, Chemistry University of California, San Diego 1967 - 1970 BA, Molecular Biology Ventura College 1965 - 1967 AA, Science & Math Experience Operations Consulting April 2006 - Present Guidant April 1993 - April 2006 Guidant 1989 - 1993 IVAC September 1984 - July 1989 IVAC August 1982 - September 1984 IVAC November 1980 - July 1982 McGaw Labs May 1973 - November 1980 Whittaker Research & Development May 1970 - May 1973 Skills Medical Devices, Manufacturing, Testing, FDA, Quality System, V&V, Continuous Improvement, ISO 13485, Biomedical Engineering, Product Development, Product Launch, Clinical Trials, Quality Assurance, Quality Management, CAPA, GMP, Pharmaceutical Industry, Validation, R&D, Design Control, Commercialization, Cross-functional Team., 21 CFR Part 11, Design of Experiments, Biotechnology, Market Development, Process Simulation, Regulatory Affairs, Change Control, Lifesciences, Technology Transfer, DMAIC Show more