Ronen Shtekel Email & Phone Number

Latham, New York, Us

Austin, Tx, Us

Management of quality and regulation in a medical device company. The company developed a mobile, clinical-grade medical device for home use. The device contains a sensor unit that records and transmit vital signs using an application that is installed on a smartphone. The following medical test can be performed by the users; ECG, Heart Rate, Body Temperature and Peripheral blood oxygen saturation level. Among my roles Quality system qualification according to the requirements of ISO13485, MDR, MDD, FDA and UDI. Responsibility for all quality issues in manufacturing and development including validations, complaints, CAPA, NCR, supplier’s certification, equipment calibration, sterilization, Safety & EMC compliance. Technical files and FDA submissions.

Cherry Hill, Nj, Us

Management of quality assurance and regulation in a medical device company. The company developed an RFID enabled surgical item visibility solutions for hospitals and sterilization centers. Quality management system according to the requirements of ISO13485, MDD, GMP and UDI Responsibility for all quality issues in manufacturing and development including validations, CAPA, NCR, suppliers approval, sterilization, Safety & EMC compliance.

Caesarea, Israel, Il

The company developed minimal-invasive Cryoablation medical system. Quality management system according to the requirements of ISO13485, MDD and GMP. Responsibility for all quality issues in manufacturing and development including validations, complaints, CAPA, NCR, suppliers approval, sterilization, Safety & EMC compliance.

Management of quality assurance in a medical device company. The company developed a ultrasonic and RF system for the treatment of cellulitis. Maintaining a Quality system according to the requirements of ISO9001, ISO13485, MDD, GMP and Canada. Responsibility for all quality issues in manufacturing and development.

London, England, Gb

Management of quality assurance and regulation in a medical device company.The company developed a needle free injection system for administration of medication and esthetic fillers for skin rejuvenation. Operated and qualified a quality system according to the requirements of ISO9001, ISO13485, GMP and Canada. Responsibility for the registration of company's products around the world (Canada, Asia, Australia, Europe). The role included responsibility for all quality issues in manufacturing and development, including suppliers and sterilization, Safety & EMC compliance.

Management of quality assurance and regulation. The company developed ultrasonic diagnostic systems. Attained qualification system according to the requirements of ISO9001, ISO13485, GMP and Canada. Responsibility for the registration of company's products around the world (Canada, Asia, Australia, Europe).

Management of quality assurance and regulation. International medical device company. In the role of the job act to attain qualification requirements of ISO13485 quality and GMP's - FDA. Responsibility for the registration of company's products around the world (Canada, Asia, Australia, Europe, Israel - AMAR). Established and implementing a software for quality management of service and nonconforming products.

Ness Tziona, Il

Management of quality assurance operations. Payton is an international company developing and manufacturing communications, switching and power transformer. The company leading line for planar transformers outstanding high efficiency in a wide ranging of applications. The company is authorized to ISO9001. In the role of the job I have acted to attain qualification to the requirements of ISO9001 and attain qualification for the environmental standard ISO14001. Conducted an extensive team of workers in the field of quality assurance, incoming inspection, line inspection, electric testing laboratory. Established and implemented a dedicated quality assurance software for the management of the quality in the organization.

Management of quality assurance and regulation in a medical diagnostics device company.NSI is an international company which developed the PAPNET system a computerized system for the diagnostics cervical cancer. The company received the approval of the FDA (PMA). In the role of the job I have acted to attain qualification requirements of the GMP's FDA and ISO9001.

Management of quality assurance and engineering in a medical diagnostics device company. Myriad developed an ultrasonic system for diagnosing of osteoporosis. The quality system operated according to the requirements of ISO 9001. I have written quality procedures, production, work instructions and specifications.

Management of quality assurance and technologies in a subcontractor electronics assembly company. In this role, I've established the quality system, I wrote and implemented procedures meeting quality requirements of ISO9002, production processes. I also implemented a system to control - ESD. Responsible for the technological processes: the wave soldering, REFLOW soldering, SMD placer and ICT testing. I also established a system for handling MRP databases control Factory: employees, wages, suppliers customers, quality.

Haifa, Il

Researcher at the NDT laboratory - Non Destructive Testing of the Quality Assurance department at the Technion institute. The subject was analysis of the sensitivity of detection by radiography and natural Gamma radiation sources Co-60 and X-Rays, analysis by digitisation of radiographs. Instructor at the laboratory of radiography and Laboratory for non destructive testing.

Haifa, Il

Composite Materials Mechanics lab - Design, development and construction of sophisticated electronic research equipment.Electronics Department of the Faculty of Physics - Electrician, development planning, construction and maintenance of advanced laboratory equipment. Optoelectronics Physics Laboratory - Research Assistant, Assembly of a gases interferometry in a vibrating medium (Stephen Lipson).

M.Sc, Quality Assurance & Reliability

B.A, Physics