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In?this?role,?you?have?the?opportunity?toAs?a?complaint?investigator,?you?will?support?MDR/adverse?event?reporting,?triage?complaint?records,?manage?high-risk?complaints?to?CA.You?are?responsible?forLeads?team?of?investigators?responsible?to?evaluate,?investigate,?and?resolve?complaints.Completes?initial?assessment?of?reportability?and?escalate?to?the?manager?when?necessary?to?determine?action.Analyzes?complaint?data,?gathers?additional?data?as?needed,?and?partners?cross?functionally?to?share?feedback?to?the?development?and?manufacturing?teams?on?potential?product?improvements,?product?defects,?and?safety?evaluations,?and?resolve?complaints.Ensure?accurate?documentation?of?evaluation?and?investigation?results?with?the?assigned?complaint?records.??Completes?initial?assessment?of?reportability?and?escalates?to?manager?to?determine?action,?when?necessary.??Ensures?timely?medical?device?reporting?by?assessing?complaints?against?reporting?requirements?and?facilitating?any?required?further?investigation.?Write?and?submit?medical?device?reports?(MDRs)?and?/?or?regulatory?reporting.Provides?consultation?to?investigator?during?initial?check/?reportability?determinationProvides?review?of?complaint?to?ensure?all?information?needed?for?Reporting/MDRs?is?present;?determine?if?further?investigation?is?needed?and?track?investigation?to?conclusionAnalyzes?complaint?data,?gathers?additional?data?as?needed,?and?partners?cross?functionally?to?share?feedback?to?the?development?and?manufacturing?teams?on?potential?product?improvements,?product?defects,?and?safety?evaluations,?and?resolves?complaints.??Assist?in?trending?of?complaints?and?collaborate?with?the?appropriate?groups?to?ensure?that?the?data?got?pushed?to?the?appropriate?departments?for?actions.Support?reviews?and?audits?assigned.Support?Product?Hold?review,?CAPA?review;?PMRA;Other?post?market?surveillance?tasks.You?are?a?part?ofThe?Emergency?Care?and?Resuscitation?Solutions?(ECR)?Post?Market?Surveillance?Team?is?headquartered?out?of?Andover,?MA.??We?welcome?you?to?join?Philips?HealthTech?as?a?Complaints?Specialist?supporting?ECR.?The?Quality?and?Regulatory?team?enables?meaningful?innovation?for?our?customers?by?partnering?with?and?guiding?the?business?to?achieve?world-class?quality?and?regulatory?compliance?in?a?rapidly?changing?environment,?while?creating?a?great?workplace?for?our?people?to?realize?their?career?aspirations.To?succeed?in?this?role,?you?should?have?the?following?skills?and?experienceBachelor's?degree?required.?Technical?degree?in?scientific?or?healthcare-related;3?years' experience?working?in?a?post?market?role?preferred.Experience?with?Complaint?Handling?Software,?Databases,?and?Microsoft?Office.Excellent?communication?skills?(verbal,?written,?and?presentation)Medical?device?and?or?other?regulated?industry?(Pharma,?IVD)?preferredBasic?knowledge?of?ISO13485Local?post?market?surveillance?regulation?(21CFR,?MDD,?EU-MDR?and?other?applicable?market?regulation)?and?ISO14971;Previous?experience?in?medical?device?and?or?applicable?product;Product?knowledge?is?preferred.Ability?to?effectively?manage?time.Ability?to?handle?multiple?task?assignments.In?return,?we?offer?youAt?Philips,?we?strive?to?make?the?world?healthier?and?more?sustainable?through?innovation,?and?our?goal?is?to?improve?the?lives?of?3?billion?people?a?year?by?2025.??This?position?offers?the?opportunity?to?influence?regulatory?compliance?worldwide?and?directly?improve?the?customer?and?patient?experience.??We?offer?competitive?health?benefits,?a?flexible?work?schedule?and?access?to?local?well-being?focused?activities. 職能類別：質量管理/測試經理(QA/QC經理) 關鍵字：質量管理