Job?Description:a)?ResponsibilitiesAssure?Quality?Systems?are?compliant?to?the?customer?Quality?requirements?as?well?as?regulatory?requirements?(including?FDA?Quality?System?Regulations,?GMPs?and?ISO?guidelines,?MDD?and?93/42/EEC,?etc.)?throughout?all?design?and?manufacturing?activities.Provide?Leadership?in?Quality?Excellence?for?the?global?business?in?Systems,?People,?Processes?and?Products.Maintain,?improve?and?drive?the?comprehensive?quality?program.b)?ManagerialDefine,?direct?and?follow?up?with?all?concerned?parties?in?establishing,?executing,?and?monitoring?strategic?and?tactical?aspects?of?product?quality?programs.Jointly?develop?and?drive?deliverables?to?meet?the?company?compliance?and?quality?management?system?goals.Identify?top?priority?quality?issues?and?develop?action?plans?that?support?the?company?business?strategy.c)?StrategicIdentify?and?resolve?compliance?and?quality?related?issues?at?the?root?cause?level?to?prevent?problems?from?re-occurring.??Focus?on?preventive?action?to?minimize?resource?and?schedule?impacts.Review?all?projects?throughout?their?life?cycle?for?quality?improvement?opportunities,?risks?to?quality,?and?counter?measures?to?quality?risks.Develop?and?deploy?an?executive?level?summary?on?compliance?and?quality?program?progress.Daily?Duties?include:Lead?the?overall?quality?functions?for?all?facilities?including?incoming/in-process?and?outgoing?inspection,?issue?containment?and?corrective?actions.Work?directly?with?suppliers?to?dramatically?improve?overall?product?quality.??Drive?improvements?to?their?overall?quality?systems.Drive?issue?resolution?with?engineering,?manufacturing?and?suppliers.Oversee?the?supplier?certification?program.??Ensure?supplier?report?card?process?is?in?place.??Generate?appropriate?performance?metrics?and?drive?resolution?of?issues.Develop?and?drive?department?projects?such?as?reducing?the?need?for?incoming?inspections,?vendor?to?stock?improvement,?electronic?certificates?of?compliance?and?parallel?audit?expansion.Travel?to?all?facilities/suppliers?to?review?and?enhance?their?effectiveness?and?capabilities.Review?Quality?Assurance?plans?for?NPD?including?OEM/ODM?projects?and?ensure?appropriate?quality?control?processes?are?in?place.Participate?in?the?supplier?selection?and?qualification?process.Drive?timely?resolution?of?issues?impacting?product?quality.Review?Root?Cause?and?Corrective?Action?reports?to?verify?effectiveness?of?solutions.Work?directly?with?Customers,?NPD?and?Production?Team?to?ensure?the?highest?quality?level?possible?products?are?built.Position?Requirements:Four?Year?Bachelor’s?degree?in?an?engineering?or?quality?discipline.Minimum?of?8?years?quality?assurance?experience.Extensive?current?experience,?and?successful?track?record?as?Quality?Manager?in?either?manufacturing?operations?or?international?subcontract?manufacturing?operations.Strong?knowledge?of?manufacturing?quality?management?in?China?is?a?must.Solid?experience?in?medical?device?manufacturing?field?is?highly?preferred.Three?years?experience?in?Six?Sigma?Methodology?–?Black?Belt?preferred.(Statistical?Process?Control,?Failure?Modes?&?Effects?Analysis,?Measurement?System?Analysis,?Process?Capability?Studies,?Corrective?&?Preventive?Action,?Root?Cause?Analysis?and?Risk?Analysis)Highly?motivated?individual?who?can?work?independently;?detail?oriented?with?excellent?follow?up?skills.Fluency?in?Mandarin?and?English?language?skills?a?must?(written?and?verbal).Interpersonal?skills?-?exceptional?listening,?understanding,?influencing?and?communication?(written?and?verbal),?and?presentation?skills?-?politically?astute.
