Quality assurance and regulation management in a medical device, system qualification according to the requirements of the FDA 21 CFR Part 820, cGMP, MDD, IVDD, ISO9001, ISO13485 in US, Canada, Europe and Far East. Complete responsibility and management of QA operations. Writing and implementation of quality procedures and SOP's. R&D quality processes, responsibility of complaints handling, CAPA. Incoming in-process and final inspections. Approval of products for release and management of nonconforming material. Internal audits. Approval and evaluation of suppliers. Sterilization process; definition, approval and validation; EtO, Gamma, Steam Engineering: Supporting the product engineering from the development phase, transfer to production. Testing the components of the system and a preparation production files. Engineering change control (ECO). Environmental testing for temperature, humidity, vibration, Safety and EMC.Production: Planning and definition of technological processes for production of electronic, optical, mechanical assemblies complying with quality and workmanship standards. Profound acquaintanceship of ERP systems such as Priority, Mfg-Pro. Following modules; service, complaint, rejection, warehouse management, configuration control, product tree, part numbering, purchasing, supplier and subcontractors management.Computing: Excellent ability with computerized systems and fluent work with vast software applications; Excel, Word, Access, PowerPoint, Visio, Quality applications, Agile, Statistical SW, Operating systems and computer hardware.R&D: Experimental physicist in the fields of Optics, Infra-red systems and image processing. Methods of Non–destruction testing, ultrasonic, radiographic and others.Mechanics: Comprehension of mechanical complex systems