Electrical Engineering Professional with extensive expertise in all aspects of manufacturing engineering, medical device quality assurance and hardware supply chain engineering honed at key divisions of Varian, GE, Litton Applied Technology Division, Xerox and the Department of Energy. Effectively analyzes, designs and implements quality control processes and tools to ensure product reliability, global regulatory compliance and customer satisfaction requirements are integrated throughout R&D and manufacturing phases of the product lifecycle. Successfully achieves objectives through personal credibility and relationship management across functional groups and at all organizational levels. CERTIFICATION• Certificate – ISO 13485 Quality Management Standard for medical devices• Certificates – QSR Elements (Management, Training, Validation, Failure Investigations, Auditing)• Medical Devices Certificate – EU Directives, Guidance, CE MarkingSpecialties: ISO 13485 Compliance • Corrective and Preventative Actions (CAPA) • FDA 21 CFR 820 Compliance • Electro-mechanical Design • New Subsystem Introduction • Verification/Validation • Supply Chain Management • Product Safety • Cost Control