衡阳招聘

1. Principal Duties and Responsibilities (General Summary, essential functions and authorities, etc.)

主要工作职责（基本概况，主要功能，权限等）

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 Sr. Quality Engineer, maintain and improve complaint management systems.

作为高级质量工程师负责维护并改进投诉处理系统。

• Participate internal, external audit and JJRC audit related with complaint.

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 judgment

  产品投诉上报及潜在不良事件初步判断

• 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.

潜在可疑不良事件初步判断

• 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。

• Review on resolution form for related complaints to ensure reasonable investigation has been performed. Discussion with your direct supervisor or Opcos if necessary.

  审阅负责的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。

• 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。

• Prepare complaint data analysis as per commercial requirement.

根据业务需求制定投诉数据分析报表。

• 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

客户质量支持

• 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 specific Franchise, customize letter if required.

针对特定产品线提供100%中文沟通信, 如需要，客制化沟通信。

• Proactive customer visits to help sales team for quality communication.

主动拜访，帮助销售进行质量相关的沟通。

• 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

• Proactively participant knowledge learning via - e-net; case study; classroom training and self-learning.

  通过各种途径学习有关知识，学习方式包括网上学习，案例分析，产品培训，及自学。

• Acted as back up for team members to build a high cohesive force and performance team.

帮助团队其它成员，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.

  按要求对可疑水货假货上报处理。

• Support on health authority supervision inspection, escalation if necessary.

配合药监的反查和协查，必要时上报。

• 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。

Other responsibilities defined in written procedures.

流程中规定的其它职责。

1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.

基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）

• Bachelor degree.

  本科学历

• 3-4 years experience in quality compliance or related areas in medical device or pharmaceutical industries.

  3-4年相关工作经验

• Good communication skills and learning ability

  良好的沟通和学习能力

• English fluent in reading, writing, oral, listening.

  流畅的英文听说读写能力（英语六级or above）

• Familiar with routine operations of computer and software.

  熟练电脑操作能力

• Capability to be flexibility with changed working process and system

  能适应不断变化的工作流程及系统

强生（上海）医疗器材有限公司诚聘