崗位職責(zé)：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(zhì)量管理系統(tǒng)的建立和實施及維護改進與相關(guān)部門和集團質(zhì)量管理部門協(xié)調(diào)，確保質(zhì)量管理體系所需的過程得到建立實施并確保維護和持續(xù)改進。1.1文件控制-?審批文件確保文件內(nèi)容符合國際本地及集團要求。-?發(fā)布文件并確保文件被執(zhí)行。-?維護本地文件清單。-?提供良好文檔規(guī)范的培訓(xùn)。1.2?QMS培訓(xùn)-?根部集團和本地要求（如ISO?13485/9001,?FDA?QSR,?中國GMP）執(zhí)行培訓(xùn)方案。-?針對培訓(xùn)管理員，提供培訓(xùn)工具的培訓(xùn)。-?與管理員一起維護數(shù)據(jù)，并更新培訓(xùn)需求表。-?監(jiān)控KPI，分析培訓(xùn)狀態(tài)并采取措施。1.3?審核-?計劃/組織/協(xié)調(diào)內(nèi)審/外審及飛行檢查。-?執(zhí)行內(nèi)部檢查/審查以確保體系的正常有效運行。.-?跟蹤所有審核發(fā)現(xiàn)按CAPA流程找到合適的原因制定措施直到關(guān)閉。1.4??持續(xù)改進-?確保集團CAPA體系在本地很好的執(zhí)行。-?審批CAPA及MIR報告。-?如需要，培訓(xùn)員工CAPA知識（如根本原因等）。-?組織協(xié)調(diào)CAPA?workshop。-?監(jiān)視KPI(QIT,?MRB,?KPIs,….)分析CPAA?狀態(tài)-?負(fù)責(zé)GLOBAL?CAPA檢查。-?維護本地CAPA?and?MIR清單。1.5?QMS體系范圍內(nèi)新/變化（工藝、設(shè)備、軟件等）的支持，如SCM/CRM/PLM-?協(xié)調(diào)新/變化（工藝、設(shè)備、軟件）的風(fēng)險評估-?審查風(fēng)險評估文檔，如FMEA.確認(rèn)，NPI，?DMR/DHR，?變更管理，供應(yīng)商管理等。-?確保所有新/變化符合法規(guī)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(zhì)量管理體系和法律法規(guī)-?及時獲取新/更新的法律法規(guī)-?與食品藥品監(jiān)督管理局等相關(guān)政府部門保持密切聯(lián)系，將質(zhì)量管理體系標(biāo)準(zhǔn)和法律法規(guī)的更新情況及時匯報給蘇州管理層及集團質(zhì)量部門，并協(xié)調(diào)在公司內(nèi)實施。-?處理或者協(xié)助處理與助聽器有關(guān)的醫(yī)療器械法規(guī)（國內(nèi)和國外）事宜，例如：生產(chǎn)許可證和產(chǎn)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(zhì)量和法律法規(guī)意識的提升在整個公司內(nèi)提高滿足法規(guī)和顧客要求的意識，以符合法規(guī)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(xué)本科或以上學(xué)歷，主修機械或電子工程或相關(guān)專業(yè)；五年以上在合資或外商獨資企業(yè)的工作經(jīng)驗2.?At?least?5?years'?experience?on?quality?management;?familiar?with?ISO9001/13485,lead?auditor?is?preferred.2.?五年以上質(zhì)量管理體系工作經(jīng)歷，有著豐富的ISO9001/13485經(jīng)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。