崗位職責：1.??QMS?set?up/?maintenance?and?continuous?improvement?Coordinate?with?relevant?departments?and?global?quality?department,?ensure?the?QMS?process?is?defined?and?implemented?and?maintained?with?continuous?improvements1.1?Take?the?role?of?Document?control?officer-?To?review?and?approve?the?documents?to?ensure?the?documents?requirements?compliance?with?global?&?international?and?local?requirements.-?To?release?the?documents?and?ensure?the?documents?released?and?implemented.-?To?maintain?the?local?overview?of?QMS?documents.-?To?provide?GDP?trainings.1.2?Take?the?role?of?QMS?Training?officer-?To?implement?the?training?concept?according?to?global?and?local?requirements,?eg,?ISO?13485,FDA?QSR,?Chinese?GMP.-?To?train?admins?on?training?tool.-?To?maintain?data?together?with?admins;?to?update?trainings?matrix?in?case?of?revisions.-?To?analyze?training?status?for?improvement,?to?monitor?KPIs?/?data?analysis.1.3?Be?responsible?for?Audit-?To?plan/organize/coordinate?the?internal?and?external?audit?and?un-announced?audit.-?To?conduct?the?internal?QMS?check/review?to?ensure?the?QMS?is?implemented?in?efficiency?way?and?on?right?track.-?To?follow?up?the?audit?findings?are?closed?with?proper?root?cause?and?actions?as?CAPA?process.1.4??Take?the?role?of?CAPA?officer?for?continuous?improvements-?To?ensure?local?implementation?of?the?global?CAPA?system?according?to?regulatory?requirements.-?To?review?and?approve?CAPA?and?MIR?Reports.-?To?train?employees?on?CAPA?topics?(RCA,…)?if?needed.-?To?implement?and?to?moderate?workshops?to?achieve?improvement?if?needed?in?regards?to?corrective?and?preventive?actions.-?To?analyze?CAPA?status,?to?monitor?KPIs?and?perform?data?analysis?(QIT,?MRB,?KPIs,….)-?To?work?on?global?CAPA?checks.-?To?maintain?local?CAPA?and?MIR?log1.5?To?provide?the?support?on?new/revised?process/equipment/software)?for?whole?QMS?scope,?SCM/CRM/PLM-?To?coordinate?the?risk?assessment?for?the?new/revised?process/equipment/software-?To?review?the?assessment?and?documentation,?eg,?FMEA,?Validation,?NPI?process,?DMR/DHR,?ECR?change?process,?supplier?management?process,?etc.-?To?ensure?the?new/changes?meet?regulatory?requirement1.?質量管理系統的建立和實施及維護改進與相關部門和集團質量管理部門協調，確保質量管理體系所需的過程得到建立實施并確保維護和持續改進。1.1文件控制-?審批文件確保文件內容符合國際本地及集團要求。-?發布文件并確保文件被執行。-?維護本地文件清單。-?提供良好文檔規范的培訓。1.2?QMS培訓-?根部集團和本地要求（如ISO?13485/9001,?FDA?QSR,?中國GMP）執行培訓方案。-?針對培訓管理員，提供培訓工具的培訓。-?與管理員一起維護數據，并更新培訓需求表。-?監控KPI，分析培訓狀態并采取措施。1.3?審核-?計劃/組織/協調內審/外審及飛行檢查。-?執行內部檢查/審查以確保體系的正常有效運行。.-?跟蹤所有審核發現按CAPA流程找到合適的原因制定措施直到關閉。1.4??持續改進-?確保集團CAPA體系在本地很好的執行。-?審批CAPA及MIR報告。-?如需要，培訓員工CAPA知識（如根本原因等）。-?組織協調CAPA?workshop。-?監視KPI(QIT,?MRB,?KPIs,….)分析CPAA?狀態-?負責GLOBAL?CAPA檢查。-?維護本地CAPA?and?MIR清單。1.5?QMS體系范圍內新/變化（工藝、設備、軟件等）的支持，如SCM/CRM/PLM-?協調新/變化（工藝、設備、軟件）的風險評估-?審查風險評估文檔，如FMEA.確認，NPI，?DMR/DHR，?變更管理，供應商管理等。-?確保所有新/變化符合法規要求。2.?QMS?and?RA(Regulatory?Affairs)?-?Retrieve?the?latest?new/revised?regulatory?and?standards-?Keep?communication?with?CFDA?and?local?government?to?share?the?latest?updates?to?local?management?and?global?quality?department,?and?coordinate?for?implementation??-?To?assist?for?regulatory?affairs?handling,?eg,?manufacturing?license,?and?product?registration,?etc.2.?質量管理體系和法律法規-?及時獲取新/更新的法律法規-?與食品藥品監督管理局等相關政府部門保持密切聯系，將質量管理體系標準和法律法規的更新情況及時匯報給蘇州管理層及集團質量部門，并協調在公司內實施。-?處理或者協助處理與助聽器有關的醫療器械法規（國內和國外）事宜，例如：生產許可證和產品注冊證等。3.?Promotion?of?quality?and?RA?awareness?To?share?and?promote?the?quality?and?RA?awareness?to?ensure?the?regulatory?compliance?and?customer?satisfaction?improvements.3.?質量和法律法規意識的提升在整個公司內提高滿足法規和顧客要求的意識，以符合法規要求和提升顧客滿意度。崗位要求：1.?University?graduates?or?above?in?Mechanical?Engineering,?Electronic?Engineering?or?their?equivalent;?At?least?5?years'?working?experience?with?a?joint-venture?or?wholly?foreign?owned?company.1.?大學本科或以上學歷，主修機械或電子工程或相關專業；五年以上在合資或外商獨資企業的工作經驗2.?At?least?5?years'?experience?on?quality?management;?familiar?with?ISO9001/13485,lead?auditor?is?preferred.2.?五年以上質量管理體系工作經歷，有著豐富的ISO9001/13485經驗，最好持有國家主任審核員資格證書；3.?Good?communication?skill?and?fluent?in?English.3.?良好的英語水平和溝通能力。
