J&J Family of Companies Quality Engineer in Shanghai, China

  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。
  1. 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。

  • 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. Support on business:

§ Provide service on 100% Chinese customer response letter. Customized communication letter if it is requested.

为Ethicon提供100%中文投诉调查报告服务。如有需求,提供定制化的客户沟通性。

§ Develop complaint related communication skills and established leaflet to distribute to sales team and improve it continuously.

制定并宣传投诉沟通技巧手册,并不断的完善。

§ Prepare monthly product quality related story sharing-Focus on product quality

准备月底产品质量相关的故事分享-聚焦产品质量的宣贯。

§ Connect with sourcing company periodically for complicated cases and provide solutions to customers.

定期跟国外母公司沟通复杂案件及为业务部门提供解决方案。

§ Support on customer visit to show our attention to customers and collect more useful information for further analysis

提供客户拜访支持表达我们对客户的重视,以及进一步收集并获取有用的信息以便后续分析。

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

China-Shanghai-Shanghai

Organization

Johnson & Johnson Medical Shanghai Ltd. (7055)

Job Function

Quality (Generalist)

Requisition ID

1700193178W