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工作地點: 常州市 招聘人數: 1人 工作性質: 全職
工作經驗: 5年以上 學歷要求: 本科 年齡要求: 不限
性別要求: 不限 薪資待遇: 面議 更新日期: 2019-10-17

崗位職責:

    工作綜述Job Function:
    Ensures Biomet products meet applicable requirements for sterility, cleanliness and biocompatibility. Be the in-house expert on all issues related to sterility, biocompatibility testing and critical systems testing and monitoring. Interface with regulatory agencies and auditors as required to ensure that the sterility program is fully compliant with QSR & ISO requirements.
    確保Biomet的產品符合無菌、潔凈度和生物相容性的相關要求。是有關無菌、生物相容性測試和關鍵系統測試和監測的所有問題的公司內部專家。是監管機構和審核員接口以確保無菌項目完全符合QSR和ISO的要求。
    The overall responsibility of this position is to maintain and implement validation procedures. Dispose the quality issues for group (such as complaints from sending sites, internal critical MRB issues, daily MRB review, etc.)
    全面負責工廠內的確認程序和實施,負責小組內各種質量問題的處理(外部發送方投訴處理、內部重大MRB處理、每日MRB評審等)。
    工作職責Job Description
    Assign work and evaluate performance for group members
    對小組成員工作安排和成績評估
    Work with QC to complete the inspection during project transfer
    協調QC資源完成項目轉移中的檢驗
    Establish and maintenance quality control plan.
    創建和維護質量控制計劃。
    Any SQC requirements and process capability analysis.
    滿足標準質量控制要求和完成過程能力分析。
    CAPA follow-up.
    CAPA跟蹤。
    As leader of daily MRB, deal with Internal/external NCR and SCAR from send site.
    主持每日MRB,處理內部、外部NCR和SCAR.
    Follow up and define containment.
    跟蹤和制定圍堵措施。
    QMS procedure follow-up.
    執行QMS程序。
    Train technicians in proper microbial and particulate sampling techniques, and monitor the sampling program to assure accurate results.
    對技術員進行適當的微生物和微粒抽樣技術培訓,并對抽樣項目進行監測以確保取得正確的結果。
    Train and provide technical support to technicians performing required tests on the RO/DI water system, compressed air system and other critical systems as required.
    對技術員進行培訓并提供技術支持以進行RO/DI水系統、壓縮空氣系統和其他關鍵系統要求的測試。
    Maintain tracking/trending reports on microbiology/sterility related issues for management review.
    維護微生物/無菌相關問題的跟蹤/趨勢報告以供管理評審。
    Provide technical support for clean room design and maintenance.
    為潔凈室的設計和維護提供技術支持。
    Provide technical support for equipment and process validation.
    為設備和工藝的確認提供技術支持。

職位要求:

    Bachelor's degree (B. A.) in microbiology, from four-year college or university; and five years related experience and/or training; or equivalent combination of education and experience.
    微生物學四年本科學歷;五年相關工作經驗和/或培訓;或同等教育程度和經歷。
    Ability to utilize basic statistical methods for analyzing data.
    能夠運用基礎的統計方法分析數據。
    Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
    能夠解決實際問題并在只存在有限變量時處理各種各樣的確定變量
    Microsoft Office, Minitab or equivalent.
    微軟辦公系統,統計軟件或同等軟件。
    Professional and ethical conduct
    專業的道德操守
    Committed to strive for excellence in the execution of required responsibilities
    在執行要求的職責時能夠致力于追求卓越
    Committed to continuously improve English communication skills and cultural awareness
    致力于不斷提高英語溝通能力和文化意識
    Committed to continuously learn as needed to perform the required responsibilities
    致力于不斷學習以執行所要求的職責
    Learn the regulatory requirements for the Medical Device Industry
    學習醫療器械行業的法規要求
    Good interpersonal and communication skills
    良好人際溝通技能。
    備注:薪資為系統默認選擇,請忽略。
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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