by simplify complicated questions , tracking status well and leading customer when they struggling to get excellent supplier evolution ranking report ,score is more then 90 alwaysPresented and demonstrated statement to Tier1 Glucose Meter VP in Launch meeting per 6 month. 4.Quality System Skill 4.1 Regulation : ISO13485,14971,15197 , Electronic Records; Electronic (ERES) , FDA part 820 and SWV model) 4.2 Leading Development Quality Assurance task : Failure mode and effect analysis (FMEA) , customer complaint handing (robust CAPA) , Validation , audit supplier , RoHS , Quality Plan , Training , system/SOP improved Senior Engineer For Glucose Meter Strip R
Full-time / Interested in working remotely
National Defense Medical Center・
Biochemistry