1. ·EstablishesandmaintainsQualityManagementSystemensuringthatdesign,manufactureandproductperformanceconformstoestablishedcompanyandregulatorystandards.·Establishstrategicplanstofacilitatecompliancewithdomesticandinternationalregulations,includingFDAQualitySystemsRegulations,ISO13485,EUMDD,etc.·PartnerswithR&D,engineering,manufacturingandsales/marketingtoensurequalityisdesignedandmanufacturedintoproduct.·Possessesthenecessaryindependence,authorityandresponsibilitytoinitiateactiontopreventnonconformities,enactremediationplans,identifyanddocumentqualityproblems,initiate,recommend,provideandverifysolutionstoqualityproblemsanddirectorcontrolfurtherprocessinganddeliveryofnonconformingproduct.·Establishprocedurestoensurethatthequalityprogramwillmeetorexceedinternalandexternalcustomerneedsandexpectations.·EstablishesandmonitorsmetricsforthemeasurementofQualityindicatorsandqualitycoststoensureeffectivenessandvaluetothebusiness.·Interactswithcustomersandvendorstoprovidetechnicalsupportformaterialconcerns/problemsandrespondstocustomerinformationrequests.·ServeasthesiteManagementRepresentativetoprovideregularreportsonthestatusofthequalitysystemtoexecutivemanagement.·Maintainsqualityassurancestaffthroughcoaching,developmentandtraining.·Achievesfinancialobjectivesbypreparingthequalityassurancebudget;schedulingexpenditures;analyzingvariances;initiatingcorrectiveactions.
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