I am Shebl Mohamed Experienced Plant, production, quality Manager, and MD lead auditor ISO13485 with a demonstrated history of working in the medical device industry for more than 20 years participate in manufacturing of many products such as SWMD dental implant planner software, IV cannula, hemodialysis blood lines, IV fistula, infusion, nelaton catheters, hypodermic syringes, oxygen mask, breathing circuits, Guedel air way, urine bags, and many other products. Skilled in medical writing of RISK MANAGEMENT, CLINICAL EVALUATION, CAPA, VIGILENCE, PMS, PMCF, INTERNAL AUDITING, MANAGEMENT REVIEW, MANY OTHER QUALITY MANAGEMENT SYSTEM DOCUMENTATION WHICH COMPLY MDR 2017/745, MEDDEV 93/42, ISO13485 .Experienced in MDSW documentation, process validation (IQ, OQ, and PQ), EOG sterilization process validation (MPQ, PHYSICAL PQ) and routine control of sterilization cycles, clean room validation, software validation according risk arising from software failure, manufacturing processes (injection, extrusion, printing, assembly, packaging, packing), physical, chemical, and microbiological testing. Skilled in data analysis using R, PYTHON, MINITAB, TABLUE, SQL, access database, Excel, and Google spread sheets. Strong engineering professional with a Bachelor's degree focused in physics &chemistry from faculty of science , Master degree of business administration, LEAN SIX SIGMA green belt from AAST, advanced data analysis Nano degree from UDACITY school USA, Statistics with Python which contain 3 courses understanding ,visualizing data with python course , Inferential statistical analysis with Python course and fitting statistical models to data with python from Michigan university USA, and Google data analytics professional certificate .