Quality Assurance: Over twenty years of solid experience in electro-mechanical manufacturing and Pharmaceutical, medical devices industries. * In-depth knowledge of, quality assurance, process control, cleaning, auditing and product improvement. * Provide interface between design/development engineering, manufacturing and software testing. Strong analytical problem solving skills. * Specialized in Statistical Process Control (SPC), conducting FMEA's, CAPA, DOE's Total Quality Management (TQM), 21 CFR 210, 211, 820, 801, 803, 806, ISO13485, MDD, and CMDR. * Provide procurement and manufacturing services for all products and technical interface with suppliers and customers. * Detailed understanding of AS9100, ISO 9001 requirements and cost control activities.