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任務(wù)/職位簡述 Mission/Position Headline： 執(zhí)行總體質(zhì)量任務(wù)和戰(zhàn)略，并確保所有分配的質(zhì)量領(lǐng)域的相關(guān)質(zhì)量方針和指導(dǎo)的實(shí)施。Implements overarching Quality mission and strategy, and ensures implementation of related Quality policies and guidelines, for all assigned quality areas. 職責(zé)領(lǐng)域 Areas of Responsibilties:： ? 確保上海工廠質(zhì)量體系的實(shí)施和改進(jìn)，包括質(zhì)量保證（如文件、培訓(xùn)、內(nèi)部審核等）和質(zhì)量工程（如CAPA、不合格品管理、工藝驗(yàn)證等）。Ensures implementation and improvement of Shanghai facility quality system, including Quality Assurance (e.g., Documentation, Training, Internal Audit, etc.) and Quality Engineering (e.g. CAPA, Nonconformance management etc.). ? 擔(dān)任上海工廠質(zhì)量體系管理者代表，在外部質(zhì)量體系核查時(shí)作為代表參與現(xiàn)場核查。Serve as the Shanghai Quality System Management Representative and represent the site during external regulatory inspections. ? 與各職能部門溝通，在產(chǎn)品生命周期中提供法規(guī)指導(dǎo)，包括質(zhì)量管理體系要求，標(biāo)簽要求、注冊要求，注冊時(shí)限以及監(jiān)管機(jī)構(gòu)的期望。Interface with a variety of functional groups to provide regulatory guidance regarding the management of issues throughout the product life cycle, including QMS requirements, labeling requirements, registration requirements and timing, and expectations of the regulatory bodies. ? 收集相關(guān)法規(guī)和標(biāo)準(zhǔn)信息，及時(shí)了解政策趨勢。Collect related regulation and standard information, keep update on local trend and policy. ? 雇傭、培訓(xùn)和發(fā)展上海相關(guān)質(zhì)量和注冊團(tuán)隊(duì)。Hire, train and develop the Shanghai-based related Quality and regulatory team. ? 其他上級或公司交代的項(xiàng)目或任務(wù)。 Other related projects or tasks assigned by superior or company. 經(jīng)驗(yàn)Experience ? 至少8年以上醫(yī)療器械和/或藥品行業(yè)工作經(jīng)驗(yàn)，有IVDD\CE\FDA經(jīng)驗(yàn)者優(yōu)先考慮。A minimum of 8 years in the medical device and/or pharmaceutical industry with at least 5 years in a quality system management role . Prior IVDD\CE\FDA experience highly desired. ? Be familiar with the regulations of medical devices, have the experience in quality management, and have strong capability to handle the problem in production management and quality management 熟悉醫(yī)療器械法律法規(guī)，具有質(zhì)量管理的實(shí)踐經(jīng)驗(yàn)，有能力對生產(chǎn)管理和質(zhì)量管理中的實(shí)際問題作出正確的判斷和處理。 ? Have the knowledge of medicine, laboratory science, biology, immunology or pharmacy with the practical experience ? 應(yīng)當(dāng)具有醫(yī)學(xué)、檢驗(yàn)學(xué)、生物學(xué)、免疫學(xué)或藥學(xué)等相關(guān)的專業(yè)知識，并具有相應(yīng)的實(shí)踐經(jīng)驗(yàn)。 ? 有接待/參與質(zhì)量體系核查的經(jīng)驗(yàn)，如NMPA、公告機(jī)構(gòu)。Experience in hosting/participating in quality system inspections, e.g., CFDA, Notified Bodies. ? 有質(zhì)量體系審核經(jīng)驗(yàn)，如有IVDD制造商經(jīng)驗(yàn)優(yōu)先考慮。Quality system auditing experience and prior experience in an IVDD manufacturing environment is preferred. ? 有工廠建立和質(zhì)量體系實(shí)施經(jīng)驗(yàn)者優(yōu)先考慮。Prior experience with facility start-ups and quality system implementation is a plus. ? 與上海市藥品監(jiān)督管理局有直接聯(lián)系并與國家藥品監(jiān)督管理局保持良好聯(lián)系者優(yōu)先考慮。Direct hands on experience and relationship with Shanghai FDA and good contact with NMPA will be plus. ? 至少5年管理經(jīng)驗(yàn)并具備人力發(fā)展能力。At least 5 years of management experience and demonstrated competence in personnel development. ? 開放性思維和良好的團(tuán)隊(duì)建設(shè)和領(lǐng)導(dǎo)力。Open-mind and Strong team building and leadership skills. ? 具備識別優(yōu)先級以及同時(shí)處理多個(gè)任務(wù)的能力，抗壓能力強(qiáng)。Ability to prioritize and juggle multiple projects and thrive under pressure. ? 較強(qiáng)的溝通和表達(dá)能力。Strong communication and presentation skills. ? 良好的英語口語和書面表達(dá)能力。Good oral and written English is required. 教育Education ? 本科以上學(xué)歷，生物學(xué)、生物醫(yī)學(xué)工程、醫(yī)學(xué)、工程或科學(xué)學(xué)科相關(guān)專業(yè)。Bachelor degree or above, major in biology, biomedical engineering, medicine, engineering or science discipline related.