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>>查看公司介紹 RC Specialist...

工作地點: 常州市 招聘人數: 1人 工作性質: 全職
工作經驗: 1年以上 學歷要求: 大專 年齡要求: 不限
性別要求: 不限 薪資待遇: 6000-9000 更新日期: 2019-11-22

崗位職責:

    主要工作職責(7 ±2條) Principle Duties and Responsibilities (7 ±2 items)
    Be responsible for establishing and revising relative system documents;
    負責相關體系文件的編制或更改;
    Be responsible for the standardization, distribution, withdrawing, obsoleting and archiving of non-technical system documents, including specified responsibilities of Document Controller in documents;
    負責非工藝類體系文件的標準化、發放、回收、作廢、歸檔,包括文件規定的文控員職責;
    Be responsible for following up and maintaining results of quality objective;
    負責質量目標的跟蹤和保存結果;
    Be responsible for verifying revisions of standards and regulations related with quality management system establishment by visiting relative websites;
    負責訪問相關網站來驗證用于建立質量管理體系的標準或法規是否現行有效;
    Be responsible for regulatory training;
    負責法規知識培訓;
    Be responsible for reviewing process validations, software validations, quality plans and Change Control.
    負責復核過程確認、軟件確認,質量計劃和變更控制;
    Be responsible for scheduling and following up internal audits and external audits;
    負責安排及跟蹤內部審核和外部審核;
    Be responsible for following up the progress of converting corporate procedures into ZBiomet QMS;
    負責集團文件的轉化進度的跟蹤;
    Be responsible for products notarization and legalization;
    負責產品的公證和合法化;
    Be responsible for coordinating CAPA process and follow up with CAPA progress;
    負責協調CAPA過程并追蹤CAPA進度;
    To finish temporary duty assigned by RC manager.
    負責完成法規經理指派的臨時工作。

職位要求:

    experience, knowledge, skills and credentials)
    Bachelor degree or above, major in science and engineering, more than one year’s working experience of quality management system is preferred;
    本科以上學歷,理工科專業畢業,有1年以上的質量體系管理經驗優先;
    Be familiar with ISO 9001 or ISO 13485 quality management system is preferred.
    熟悉ISO9001或ISO13485質量管理體系優先;
    To be professional and have good professional ethics;
    專業且有良好的職業道德;
    Ability to work more excellently in the task;
    在相關任務的執行中,致力于追求卓越;
    Improve oral English communicative ability and cultural sense continually;
    不斷地提升英語口頭交流能力和文化意識;
    Learn regulatory policies and rules related to medical device industry.
    學習有關醫療器械行業的法規政策及規章.
    A command of English listening, speaking, reading and writing.
    具備英語聽、說、讀、寫能力。
聯系方式
  • 聯系電話:
  • 公司地址:上海市長寧區延安西路500號萬寶國際廣場1901
  • 公司官網:http://zimmerbiomet.com
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