Johnson & Johnson Careers

Quality Manager

Shanghai, Shanghai
Quality Assurance


Job Description

Requisition ID: 1805658086W

§  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 an Assistant Quality manager, maintain and improve complaint management systems.

作为质量副经理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EHSISO13485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。

§  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 related complaints to ensure reasonable investigation has been performed. Discussion with your direct supervisor or Opcos if necessary.

审阅所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。

§   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

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

 

§   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.

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。

§   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。

 

     

 Other responsibilities defined in written procedures.


Qualifications

§   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

§   5-10 years’ experience in quality compliance or related areas in medical device or pharmaceutical industries.

5-10年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, 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)

§   Good communication and coordination, Analysis and problem-solving ability

良好的沟通,协调,分析解决问题的能力

§   Have initiative to accept the challenge, and keep learning, Adaptation to change

主动接受挑战,不断学习, 适应改变

§   Communicate with global timely after receiving abnormal complaints, organize relevant departments to analyze and find solutions.

接到客户异常投诉信息后及时和国外沟通,组织相关部门进行分析并找出解决办法

§   Need to visit key customers with relevant departments and have some communication skills.

需要与相关部门一同拜访重要客户,具有一定的沟通技巧

 



Primary Location
China-Shanghai-Shanghai
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Quality Assurance
Requisition ID
1805658086W