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工作地點: 上海市 招聘人數: 1人 工作性質: 全職
工作經驗: 8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: 25000-35000 更新日期: 2019-07-20

崗位職責:

    Job Title: Quality manager—Customer Quality

    Department: Quality & Compliance



    Principal Duties and Responsibilities
    1.1 Quality compliance 質量符合性
    § Understand documents of complaint handling requirements from 1) Global policy; 2) Opocs; 3) related government/health authority regulations
    充分理解總公司政策,母公司,及相關政府/監管機構法規對投訴處理方針文件的要求。
    § Assist direct manager to establish/optimize/implement documented system to meet relevant requirements.
    協助直接經理建立,優化,實施相關文件體系以符合相關要求。
    § As a quality supervisor, maintain and improve complaint management systems.
    作為質量主管負責維護并改進投訴處理系統。
    § Review KPIs monthly and perform improvement action continuously if necessary.
    每月審閱主要投訴指標,必要時及時采取改進措施。
    § Lead/Participate internal, external audit and JJRC audit related with complaint.
    領導/參與所有與投訴相關的內審,外審和JJRC審計。
    § Comply with EHS & ISO13485
    確保符合EHS和ISO13485的要求。


    1.2 Product Complaint reporting & Potential Adverse event preliminary investigation產品投訴上報及可疑不良事件初步調查
    § Collect complaints via format template, verify information and report complaints via ECM system as per JJMS internal & Opcos’ requirements.
    通過固定格式投訴模板收集投訴,驗證投訴內容,并根據JJMS內部及各母公司要求通過ECM系統進行上報。
    § Potential adverse event preliminary judgment from hospital or sales.
    常規醫院或銷售上報的可疑不良事件初步判斷
    § Potential adverse event investigation from health authority’s system.
    不定期收到藥監不良檢測系統中發現的可疑不良事件的反查 。
    § Additional AE work since No.1 AE regulation will be effective in 1st Jan 2019
    2019年1月1日新的醫療器械不良事件檢測和再評價管理辦法法規生效后產生的AE相關的工作。
    § Complaint handling as per requirements of related GOP/SOP/WI, reach to KPIs and continuous improvement.
    根據相關投訴的GOP/SOP/WI中規定的時間表及相關要求處理投訴,達到相關的投訴指標,并且不斷加以改善。
    § Complaint samples collection, packaging and shipping according to Opcos’ requirements.
    收集投訴樣品并按照母公司要求進行包裝并寄樣。
    § Review on resolution form for all complaints to ensure reasonable investigation has been performed. Discussion with your direct supervisor or Opcos if necessary.
    審閱所有產品投訴的分析報告,以確保其合理性,必要時與直接經理或相關母公司進行溝通。


    1.3 Complaint data analysis投訴數據分析
    § Prepare monthly report via specific format and try to optimize monthly report template.
    以特定格式準備部門抱怨月報并嘗試優化月報模板。
    § Review KPIs monthly and perform improvement action if necessary.
    每月審閱主要抱怨指標,必要時采取改進措施。
    § Have a trending analysis for related product in monthly report
    在月報中對相關產品進行抱怨趨勢分析。
    § Fast track meeting monthly with global team to discuss special or abnormal trending cases.
    每月跟國外團隊召開會議討論特殊案例或趨勢異常案例。

    1.4 Customer Quality Support and MAH related work客戶質量支持及MAH相關的工作
    § Help establish Complaint related replacement process for specific BU to meet customer’s requirement.
    針對特定產品線協助建立投訴相關的賠付流程以滿足客戶需求
    § Provide 100% Chinese customer letter delivering for all groups, customize letter if required.
    針對所有產品線提供100%中文溝通信, 如需要,客制化溝通信。
    § Collect customers’ further feedback regarding investigation result and follow up timely.
    收集客戶關于調查報告的進一步反饋并及時跟進。
    § Enhance frequency on proactive customer visits to help sales team for quality communication and handle customers’ problems with a proper way.
    加強主動拜訪頻次,幫助銷售進行質量相關的溝通并幫助客戶妥善處理各種問題。
    § Organize global experts, quality staff as well as MKT for China customer visit and case observation to monitor usage condition.
    組織國外專家來中國協同質量部,市場部等拜訪客戶并進行跟臺監測產品使用情況。
    § Fast call back response for special cases to improve customer’s satisfaction.
    針對特殊案例進行快速相應,以提高客戶滿意度。


    1.5 Training & Team building培訓和團隊建設
    § Conduct specific complaint awareness training and complaint related communication skills training to new sales team.
    對新的銷售團隊進行針對性的投訴意識培訓和投訴相關的溝通技巧培訓。
    § Arrange primary school training and other external training for new team members to build up professional team.
    為客戶質量團隊新員工安排銷售小學培訓及其他外部培訓以建立專業團隊。
    § Manage and develop talent to build a high cohesive force and performance team.
    管理并發展人員,建立高凝聚力和執行力團隊。

    1.6 Fulfill other tasks assigned.執行某些特殊項目
    § Suspected diversion or counterfeit products cases handling, escalation if necessary.
    按要求對可疑水貨假貨上報處理, 必要時進行升級。
    § Support on health authority supervision inspection, escalation if necessary.
    配合藥監的反查和協查,必要時上報。
    § Review service complaint; ensure no product complaint missed to report.
    對服務性投訴進行審閱,確保無產品投訴遺漏。
    § Provide valuable quality related support to other departments in a timely manner.
    及時給其他部門提供質量方面的支持。

職位要求:


    § Bachelor degree on pharmaceutics, medicine, medical device or related majors.
    藥學,醫學,醫療器械或相關專業學士
    § 3-5 years’ experience in quality compliance or related areas in medical device or pharmaceutical industries.
    3-5年以上的醫療器械或藥廠質量體系符合性或相關領域的經驗
    § Good leadship and be able to lead and coach subordinator.
    良好的領導力, 并能夠領導并輔導下屬。
    § English fluent in reading, writing, oral, listening.
    流暢的英文聽說讀寫能力(英語六級或以上)
    § Familiar with routine operations of computer and software.
    熟練電腦操作能力
    § Capability to be flexibility with changed working environment and system
    能適應不斷變化的工作流程及系統
聯系方式
  • 公司地址:蘇州工業園區長陽街299號
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