應屆畢業生
本科
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職位描述
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任務/職位簡述 Mission/Position Headline： 執行總體質量任務和戰略，并確保所有分配的質量領域的相關質量方針和指導的實施。Implements overarching Quality mission and strategy, and ensures implementation of related Quality policies and guidelines, for all assigned quality areas.
職責領域 Areas of Responsibilties:：
? 確保上海工廠質量體系的實施和改進，包括質量保證（如文件、培訓、內部審核等）和質量工程（如CAPA、不合格品管理、工藝驗證等）。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.).
? 擔任上海工廠質量體系管理者代表，在外部質量體系核查時作為代表參與現場核查。Serve as the Shanghai Quality System Management Representative and represent the site during external regulatory inspections.
? 與各職能部門溝通，在產品生命周期中提供法規指導，包括質量管理體系要求，標簽要求、注冊要求，注冊時限以及監管機構的期望。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.
? 收集相關法規和標準信息，及時了解政策趨勢。Collect related regulation and standard information, keep update on local trend and policy.
? 雇傭、培訓和發展上海相關質量和注冊團隊。Hire, train and develop the Shanghai-based related Quality and regulatory team.
? 其他上級或公司交代的項目或任務。
Other related projects or tasks assigned by superior or company.
經驗Experience
? 至少8年以上醫療器械和/或藥品行業工作經驗，有IVDD\CE\FDA經驗者優先考慮。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
熟悉醫療器械法律法規，具有質量管理的實踐經驗，有能力對生產管理和質量管理中的實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
? 應當具有醫學、檢驗學、生物學、免疫學或藥學等相關的專業知識，并具有相應的實踐經驗。
? 有接待/參與質量體系核查的經驗，如NMPA、公告機構。Experience in hosting/participating in quality system inspections, e.g., CFDA, Notified Bodies.
? 有質量體系審核經驗，如有IVDD制造商經驗優先考慮。Quality system auditing experience and prior experience in an IVDD manufacturing environment is preferred.
? 有工廠建立和質量體系實施經驗者優先考慮。Prior experience with facility start-ups and quality system implementation is a plus.
? 與上海市藥品監督管理局有直接聯系并與國家藥品監督管理局保持良好聯系者優先考慮。Direct hands on experience and relationship with Shanghai FDA and good contact with NMPA will be plus.
? 至少5年管理經驗并具備人力發展能力。At least 5 years of management experience and demonstrated competence in personnel development.
? 開放性思維和良好的團隊建設和領導力。Open-mind and Strong team building and leadership skills.
? 具備識別優先級以及同時處理多個任務的能力，抗壓能力強。Ability to prioritize and juggle multiple projects and thrive under pressure.
? 較強的溝通和表達能力。Strong communication and presentation skills.
? 良好的英語口語和書面表達能力。Good oral and written English is required.
教育Education
? 本科以上學歷，生物學、生物醫學工程、醫學、工程或科學學科相關專業。Bachelor degree or above, major in biology, biomedical engineering, medicine, engineering or science discipline related.
注：聯系我時，請說是在江蘇人才網上看到的。
工作地點
地址：上海浦東新區上海-浦東新區西門子醫療器械有限公司
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詳細位置，可以參考上方地址信息
求職提示：用人單位發布虛假招聘信息，或以任何名義向求職者收取財物（如體檢費、置裝費、押金、服裝費、培訓費、身份證、畢業證等），均涉嫌違法，請求職者務必提高警惕。
職位發布者
Adel..HR
上海西門子醫療器械有限公司
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批發·零售
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1000人以上
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外商獨資·外企辦事處
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上海市浦東新區周祝公路278號
