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工作地点: 上海市 招聘人数: 1人 工作性质: 全职
工作经验: 8年以上 学历要求: 本科 年龄要求: 不限
性别要求: 不限 薪资待遇: 25000-35000 更新日期: 2020-10-24

岗位职责:

    Job Title: Quality manager—Customer Quality

    Department: Quality & Compliance



    Principal Duties and Responsibilities
    1.1 Quality compliance 质量符合性
    § Understand documents of complaint handling requirements from 1) Global policy; 2) Opocs; 3) related government/health authority regulations
    充分理解总公司政策,母公司,及相关政府/监管机构法规对投诉处理方针文件的要求。
    § Assist direct manager to establish/optimize/implement documented system to meet relevant requirements.
    协助直接经理建立,优化,实施相关文件体系以符合相关要求。
    § As a quality supervisor, maintain and improve complaint management systems.
    作为质量主管负责维护并改进投诉处理系统。
    § Review KPIs monthly and perform improvement action continuously if necessary.
    每月审阅主要投诉指标,必要时及时采取改进措施。
    § Lead/Participate internal, external audit and JJRC audit related with complaint.
    领导/参与所有与投诉相关的内审,外审和JJRC审计。
    § Comply with EHS & ISO13485
    确保符合EHS和ISO13485的要求。


    1.2 Product Complaint reporting & Potential Adverse event preliminary investigation产品投诉上报及可疑不良事件初步调查
    § Collect complaints via format template, verify information and report complaints via ECM system as per JJMS internal & Opcos’ requirements.
    通过固定格式投诉模板收集投诉,验证投诉内容,并根据JJMS内部及各母公司要求通过ECM系统进行上报。
    § Potential adverse event preliminary judgment from hospital or sales.
    常规医院或销售上报的可疑不良事件初步判断
    § Potential adverse event investigation from health authority’s system.
    不定期收到药监不良检测系统中发现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日新的医疗器械不良事件检测和再评价管理办法法规生效后产生的AE相关的工作。
    § Complaint handling as per requirements of related GOP/SOP/WI, reach to KPIs and continuous improvement.
    根据相关投诉的GOP/SOP/WI中规定的时间表及相关要求处理投诉,达到相关的投诉指标,并且不断加以改善。
    § Complaint samples collection, packaging and shipping according to Opcos’ requirements.
    收集投诉样品并按照母公司要求进行包装并寄样。
    § Review on resolution form for all complaints to ensure reasonable investigation has been performed. Discussion with your direct supervisor or Opcos if necessary.
    审阅所有产品投诉的分析报告,以确保其合理性,必要时与直接经理或相关母公司进行沟通。


    1.3 Complaint data analysis投诉数据分析
    § Prepare monthly report via specific format and try to optimize monthly report template.
    以特定格式准备部门抱怨月报并尝试优化月报模板。
    § Review KPIs monthly and perform improvement action if necessary.
    每月审阅主要抱怨指标,必要时采取改进措施。
    § Have a trending analysis for related product in monthly report
    在月报中对相关产品进行抱怨趋势分析。
    § Fast track meeting monthly with global team to discuss special or abnormal trending cases.
    每月跟国外团队召开会议讨论特殊案例或趋势异常案例。

    1.4 Customer Quality Support and MAH related work客户质量支持及MAH相关的工作
    § Help establish Complaint related replacement process for specific BU to meet customer’s requirement.
    针对特定产品线协助建立投诉相关的赔付流程以满足客户需求
    § Provide 100% Chinese customer letter delivering for all groups, customize letter if required.
    针对所有产品线提供100%中文沟通信, 如需要,客制化沟通信。
    § Collect customers’ further feedback regarding investigation result and follow up timely.
    收集客户关于调查报告的进一步反馈并及时跟进。
    § Enhance frequency on proactive customer visits to help sales team for quality communication and handle customers’ problems with a proper way.
    加强主动拜访频次,帮助销售进行质量相关的沟通并帮助客户妥善处理各种问题。
    § Organize global experts, quality staff as well as MKT for China customer visit and case observation to monitor usage condition.
    组织国外专家来中国协同质量部,市场部等拜访客户并进行跟台监测产品使用情况。
    § Fast call back response for special cases to improve customer’s satisfaction.
    针对特殊案例进行快速相应,以提高客户满意度。


    1.5 Training & Team building培训和团队建设
    § Conduct specific complaint awareness training and complaint related communication skills training to new sales team.
    对新的销售团队进行针对性的投诉意识培训和投诉相关的沟通技巧培训。
    § Arrange primary school training and other external training for new team members to build up professional team.
    为客户质量团队新员工安排销售小学培训及其他外部培训以建立专业团队。
    § Manage and develop talent to build a high cohesive force and performance team.
    管理并发展人员,建立高凝聚力和执行力团队。

    1.6 Fulfill other tasks assigned.执行某些特殊项目
    § Suspected diversion or counterfeit products cases handling, escalation if necessary.
    按要求对可疑水货假货上报处理, 必要时进行升级。
    § Support on health authority supervision inspection, escalation if necessary.
    配合药监的反查和协查,必要时上报。
    § Review service complaint; ensure no product complaint missed to report.
    对服务性投诉进行审阅,确保无产品投诉遗漏。
    § Provide valuable quality related support to other departments in a timely manner.
    及时给其他部门提供质量方面的支持。

职位要求:


    § Bachelor degree on pharmaceutics, medicine, medical device or related majors.
    药学,医学,医疗器械或相关专业学士
    § 3-5 years’ experience in quality compliance or related areas in medical device or pharmaceutical industries.
    3-5年以上的医疗器械或药厂质量体系符合性或相关领域的经验
    § Good leadship and be able to lead and coach subordinator.
    良好的领导力, 并能够领导并辅导下属。
    § English fluent in reading, writing, oral, listening.
    流畅的英文听说读写能力(英语六级或以上)
    § Familiar with routine operations of computer and software.
    熟练电脑操作能力
    § Capability to be flexibility with changed working environment and system
    能适应不断变化的工作流程及系统
联系方式
  • 公司地址:苏州工业园区长阳街299号