质量工程师-CHU-1421045W
Description
1. Documentation compliance
文件符合性
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，母公司，及相关各国政府法规对抱怨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 engineer, maintain and improve all related complaint management systems.
作为质量工程师负责维护并改进所有相关的抱怨处理系统。
When significant events are identified, escalate to line manager.
当出现重大情况时，及时通知经理。
Participant internal & external audit related with complaint.
参与所有与抱怨相关的内审和外审。
Comply with EHS & ISO13485
确保符合EHS 及ISO13485的要求。
2. Complaint handling & PAE Judgment
抱怨处理及潜在不良事件判断
Collect complaints via format template, verify information and report complaints as per JJMS internal & Opcos’ requirements.
通过固定格式抱怨模板收集抱怨，验证抱怨内容，并根据JJMS内部及各母公司要求上报。
Potential adverse event judgment.
潜在可疑不良事件判断
Complaint handling as per requirements of related GOP/SOP/WI, reach to KPIs and continuous improvement.
根据相关抱怨的GOP/SOP/WI中规定的时间表及相关要求处理抱怨，达到相关的抱怨指标，并且不断加以改善。
Complaint samples collection, packaging and shipping according to Opcos’ requirements.
收集抱怨样品并按照母公司要求进行包装并寄样。
Review on resolution form for all handled complaints to ensure reasonable investigation has been performed. Discussion with your direct supervisor or Opcos if necessary.
审阅所有产品抱怨的分析报告，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。
3. Tending analysis
趋势分析
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。
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。
4. Complaint handling training to all relevant staffs.
对相关人员进行抱怨处理培训
5. 按要求对水货假货上报处理
Diversion or counterfeit products cases handling.
6. Fulfill other tasks assigned
执行某些特殊项目
Qualifications
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
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality Assurance
Description
1. Documentation compliance
文件符合性
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，母公司，及相关各国政府法规对抱怨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 engineer, maintain and improve all related complaint management systems.
作为质量工程师负责维护并改进所有相关的抱怨处理系统。
When significant events are identified, escalate to line manager.
当出现重大情况时，及时通知经理。
Participant internal & external audit related with complaint.
参与所有与抱怨相关的内审和外审。
Comply with EHS & ISO13485
确保符合EHS 及ISO13485的要求。
2. Complaint handling & PAE Judgment
抱怨处理及潜在不良事件判断
Collect complaints via format template, verify information and report complaints as per JJMS internal & Opcos’ requirements.
通过固定格式抱怨模板收集抱怨，验证抱怨内容，并根据JJMS内部及各母公司要求上报。
Potential adverse event judgment.
潜在可疑不良事件判断
Complaint handling as per requirements of related GOP/SOP/WI, reach to KPIs and continuous improvement.
根据相关抱怨的GOP/SOP/WI中规定的时间表及相关要求处理抱怨，达到相关的抱怨指标，并且不断加以改善。
Complaint samples collection, packaging and shipping according to Opcos’ requirements.
收集抱怨样品并按照母公司要求进行包装并寄样。
Review on resolution form for all handled complaints to ensure reasonable investigation has been performed. Discussion with your direct supervisor or Opcos if necessary.
审阅所有产品抱怨的分析报告，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。
3. Tending analysis
趋势分析
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。
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。
4. Complaint handling training to all relevant staffs.
对相关人员进行抱怨处理培训
5. 按要求对水货假货上报处理
Diversion or counterfeit products cases handling.
6. Fulfill other tasks assigned
执行某些特殊项目
Qualifications
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
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality Assurance