Daniel Frenkel

Background

About Daniel Frenkel

A long and outstanding track record in all areas pertaining to Quality Assurance with over 10 years of experience in this particular field of expertise in various companies, international organizations and technologies. Experienced Quality Assurance Engineer and QA Strategist with product QA capabilities, profound technological and technical abilities and an "Out of the Box" engineering prowess, ability to perform various QA issues with the utmost sophistication and accuracy. In recent position I've served as Advanced Design Quality Assurance Engineer at Philips Medical systems Ltd. performing various processes in the medical device industry, more notably CT and MRI devices. Led various processes such as: risk management, statistical methods, reliability. Achieved product QA objectives, mitigated visible and non-visible residual risk failure in the stream of NPI products. Achieved numerous product QA objectives and design controls as well as ISO standards for medical device products in accordance with EU Medical Device Regulations (MDR) as well as FDA Regulations. Special expertise: Standards: ISO (1901,14001, 13485, 14971, AS9100). Medical Regulations: FDA 820, NDR, IEC 62366-1, FDA 21 CFR 820. Processes: V&V, FMEA, FAI, CAPA, RCA, APQP, CAR, GDP, GMP, GEP, Auditing, Lean, 5S, 6Sigma, SPC.