Description
SUMMARY * Extensive experience in the Pharmaceutical, Biomedical, and Semiconductor industries. * Well rounded Engineering and Business experience in Project and Operations Management, Quality Assurance, Applications, Equipment, Process, and Electronics Engineering. * Data driven, results-oriented, team-builder who strives to make significant, measurable contributions. * Thrives in complex, cross-functional, and dynamic environments while managing multiple projects under strict schedules and deadlines. (Excellent time management skills). * Proven track record of combining strategic planning and technology-based solutions, while creating profitable opportunities, reducing costs, and meeting business challenges. * Outstanding leadership, interpersonal, and motivational skills, with an exceptional ability to drive innovation and develop unique solutions. * Quality Assurance Engineering background with strong focus in Regulatory Compliance including the FDA, NRC, ITAR, OSHA, EPA, CE, UL, CSA, ISO 13485, and the DOT. * Extreme sense of accountability. CORE BUSINESS COMPETENCIES: * Project management and organization Engineering Design and Process Development Technology and operations management Semiconductor & Pharmaceutical Manufacturing Business / technology integration Multi-cultural diversity and Customer Focus Management of teams, clients, and budgets Multidiscipline Engineering Skills CORE TECHNOLOGY COMPETENCIES: Electronics: System and component level design, and troubleshooting of digital and analog circuits. Manufacturing: Statistical Analysis, Six Sigma, Statistical Process Control (SPC), 8D, IQ, OQ, PQ, PV, CAPA, CIP, ISO 9000 / 9001 / 9002/13485, Design of Experiments (DOE), Failure Modes & Effects Analysis (FMEA), Overall Equipment Effectiveness (OEE), Kaizen, Six Sigma, Lean Manufacturing, Technical Writing, Data acquisition & analysis, 5S Implementation, cGMP, FDA, OSHA.
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