Johnson & Johnson Careers

QA Specialist

Suzhou, China
Quality Assurance


Job Description

Requisition ID: 1905722248W

作为供应商质量管理,负责依据事业部采购控制相关程序的要求与采购、事业部供应商管理团队以及本土运营合作完成具体供应商选择和批准以及风险分类活动;参与供应商相关变更、不合格以及CAPA的处理过程;参与供应商技术评估的执行以及相关跟踪活动;依据事业部供应商质量协议程序要求维护供应商质量协议;定期为供应商绩效指标数据收集提供信息输入;以及必要时参与任何与供应商质量管理相关的活动。

 

作为供应商质量管理,负责管理所有爱惜康苏州工厂相关的供应商审核活动;根据需要主导或参与供应商审核;为年度供应商审核计划的定期审阅要求提供信息和支持;维护所有供应商审核相关记录和文件;以及必要时参与任何与供应商审核相关的活动。

 
参与和准备有关质量的内外审,积极的完成后续的整改项。支持风险管理和生产控制的管理.
 
按照文件的要求参与爱惜康国产产品进行投诉调查,及时完成相关的投诉调查报告。使用质量统计技术进行数据的分析,并每月准备月报。
 
协助直接主管参与其他与工作目标有关的任务和特别任务分配。
 

-         As the role of supplier quality management, responsible for cooperating with procurement, Franchise supplier management team and local operation for supplier selection and approval & risk category per franchise purchasing control procedures, participating in supplier related changes, NCR and CAPA handling process, participating in supplier technical assessment implementation and relevant follow-up activities, maintaining supplier quality agreement per franchise supplier quality agreement process, providing supplier performance input regularly for periodic supplier performance metric data collection, and participating any supplier quality management related activities as necessary.

 

-         As the role of supplier quality engineer, responsible for managing all Ethicon Suzhou site related supplier audit activities, leading or participating supplier audits as necessary, providing information and supporting the updating of annual supplier audit schedule for periodic review requirement, maintaining all supplier audit related records and documentations, and participating any supplier audit related activities as necessary.

 

 
  • Participate and prepare for external and internal quality audit, and complete the follow up actions actively. Support the risk management and process control.
 
  • Participate the investigation complaint for Ethicon local products per local procedure, and complete the relevant complaint investigation reports timely. Conducting the data analysis by using quality statistical technique, and prepare the monthly report.
 
  • Assist direct supervisor to participate other tasks related job objectives and special assignments.

Qualifications

-         本科学历有关材料或相关的专业;      

-         2-3年有关医疗器械或药品企业的工作经验;熟悉ISO13485, GMP等相关法规标准.

-         Undergraduate course of material or related subjects.

-         2-3 years’ experience with medical device or pharmaceutical manufacturing company. Familiar with ISO 13485, GMP and other regulatory standards.


Primary Location
China-Anhui-Suzhou-No. 299, Changyang Street, Suzhou Industrial Park
Organization
Johnson & Johnson Medical Suzhou Ltd. (7054)
Job Function
Quality Assurance
Requisition ID
1905722248W