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崗位設立的目的及目標 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

負責生物梅里埃有源儀器的本地化項目，為現(xiàn)有產(chǎn)品/新工藝提供技術(shù)支持或/和改進方案,，并主導建立本土化儀器的組裝/測試程序,，產(chǎn)品的轉(zhuǎn)產(chǎn)驗證和支持內(nèi)部/外部測試等工作，以支持本土儀器的注冊和最終商業(yè)化生產(chǎn),。

Responsible as internal point of reference to guaranty bioMerieux active instruments transfer project for localization, to provide technical support and /or improvement to existing products/processes, and lead to setup instruments assembly/testing procedures, validation , and internal/external testing for supporting local registration and final commercial production.

主要職責 / MAIN ACCOUNTABILITIES

Safety, Health & Environment /安全,，健康和環(huán)境

確保符合總部EHS方針、本地法規(guī)以及ISO14000的需求,。

Ensure compliant to global EHS policy, local regulation and ISO 14000 requirements.

學習,、掌握并執(zhí)行國家、政府職能部門,、地方的HSE法律法規(guī)要求,、標準，履行法規(guī)要求的HSE責任和義務,。

Learn, master and follow HSE laws, regulations, requirements and standards of the country, government functional departments and local governments, and fulfill the HSE responsibilities and obligations required by regulations.

嚴格遵守公司HSE規(guī)章制度,，服從公司的HSE管理，并執(zhí)行本崗位的HSE管理要求,，承諾“不傷害自己,、不傷害他人、不被他人傷害,，保護他人不受傷害“的四不傷害員工職責,。 對被賦予的工作活動做好危害辨識、風險評估,、應急預案并確保執(zhí)行安全操作規(guī)范,。有責任及時匯報HSE隱患及事故。

Strictly comply with HSE rules and regulations, and implement the HSE management requirements of this position. Promise to follow the requirement "do not harm ourselves, do not harm others, do not be harmed by others, and protect others from harm". Carry out hazard identification, risk assessment, and emergency plans for assigned work activities and ensure the implementation of safe operating practices. Responsible for reporting HSE hazards and accidents timely.

Quality and Regulation/質(zhì)量和法規(guī)

確保遵守國家藥品監(jiān)督管理局相關(guān)法規(guī),、ISO 13485 標準以及其他適用行業(yè)規(guī)范,，以支持完成公司目標。

Support the company’s goal of ensuring compliance with NMPA regulations, ISO 13485 standard and other industry codes applicable.

Project /項目

儀器本土化項目的項目管理和控制,。包含但不限于項目計劃,、風險控制等工作。對接海外轉(zhuǎn)移工廠的技術(shù)專家,，參與項目組定期會議匯報項目進展,。

Instrument localization projects management and control, including but not limited to Project plan management, Risk assessment control ,etc. In contact with sending site SMEs and report project status in regular project meeting.

轉(zhuǎn)移并本地化相關(guān)組裝和測試程序文件以適應中國當?shù)氐囊?guī)范、法規(guī),，并符合產(chǎn)品技術(shù)要求和本地強制性標準。

Transfer and localize related assembly and testing procedures to adapt to China local codes or regulations, and meet product technical requirements and local mandatory standards.

主導組裝和測試工藝研究和工藝驗證, 方案/報告的的撰寫和執(zhí)行,。解決儀器組裝和測試過程中技術(shù)難點,。

Lead Instruments assembly & testing process study & process validation including protocol/report writing, validation/study execution, etc. Solve technical issues during instruments assembly and testing activities.

主導儀器產(chǎn)品驗證包含單不限于子部件驗證、系統(tǒng)硬件/固件驗證、性能驗證等等,，方案/報告的的撰寫和執(zhí)行,。以支持產(chǎn)品注冊所需的研究報告的輸出。

Lead instrument product validation including but not limited to components validation, Hardware/Firmware validation, system performance validation, etc. Protocols and reports writing and execution to support product registration.

基于項目需求支持儀器的型式檢驗或其他驗證/確認等工作,。

Support instrument type testing or other qualification/verification activities per project required .

支持注冊資料的撰寫和整理,。

Support registration dossiers writing and preparation.

支持工廠、集團質(zhì)量以及監(jiān)管當局的良好生產(chǎn)規(guī)范和ISO 9001/ISO 13485質(zhì)量體系等審核活動

Supports site, corporate and competent authority quality system audit activities of GMP and ISO 13485 etc.

Routine Operation/常規(guī)運營

不斷優(yōu)化工藝相關(guān)程序以適應中國當?shù)氐囊?guī)范或法規(guī), 并符合產(chǎn)品技術(shù)要求和本地強制性標準,。

Keep optimization process related procedures to adapt to China local codes or regulations, , and meet product technical requirements and local mandatory standards.

解決儀器組裝和測試過程中技術(shù)難點,。

Solve technical issues during instruments assembly and testing activities.

產(chǎn)品變更驗證如產(chǎn)品組件本土化轉(zhuǎn)換驗證、產(chǎn)品設計變更（硬件和軟件等）驗證等,。

Perform validation to support Instrument change , for instance, components localization validation, instrument design change (hardware and software) validation, etc.

基于需求支持儀器的定期驗證/確認等工作,。

Support instrument periodical qualification/verification activities per required .

主導工藝風險分析和定期回顧

Lead process risk analysis (e.g. pFMEA) and review timely.

質(zhì)量事件和變更控制等并作為技術(shù)專家給與評估，并執(zhí)行分配的任務,。

Provide technical evaluation to support QE investigation and change control management , and to perform assigned tasks in time.

知識,、語言和經(jīng)驗要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

本科及以上學歷，機械,，電子,，通訊等相關(guān)專業(yè)，需要有至少5年以上的有源醫(yī)療器械研發(fā)或生產(chǎn)企業(yè)相關(guān)工作經(jīng)驗,。

Bachelor degree or above, major in active medical devices such as mechanics, electronics, communications engineering, etc. and necessary to have at least 5 years of relevant work experience in active medical device R&D or production companies

語言技能：英語和中文聽,、說、讀,、寫熟練,，有歐美外資企業(yè)工作經(jīng)驗者優(yōu)先。熟練操作Word和Excel等辦公軟件,。

Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese, applicants with working experience in European and American foreign-funded enterprises will be given priority, Proficient in operating office software such as Word and Excel.

了解醫(yī)療儀器產(chǎn)品注冊法規(guī),，了解儀器產(chǎn)品型式檢驗者優(yōu)先。

It will be given priority that knowing about Medical Instrument type testing and medical instrument registration regulatory

良好的機械,、電子電路故障解決能力者優(yōu)先, 對儀器組裝和測試有一定的動手操作能力,。

It will be given priority that good capability to solve mechanical/ electronic circuit issues, and have practical operation ability for instrument assembly and testing.

具備豐富的儀器產(chǎn)品轉(zhuǎn)產(chǎn)和產(chǎn)品驗證經(jīng)驗者優(yōu)先。

It will be given priority that candidate who has rich experience in instrument product technical transfer and product verification field.

有良好的團隊合作能力,。

Good Interpersonal skill and team player.

熟悉ISO 19001, ISO 13485, ISO 14971, GMP等醫(yī)療器械及生物安全等相關(guān)的法規(guī)規(guī)范者優(yōu)先,。

Be familiar with relative medical device regulation and bio-security and other codes, such as ISO 19001, ISO 13485, ISO 14971 and GMP ，will be given priority