Johnson & Johnson Careers

Ass. Quality Manager

Shanghai, Shanghai
Quality (Eng)

Job Description

Requisition ID: 1805658083W

1.1.   Support the quality manager to maintain and improve quality system compliance in JJMS as per ISO13485, J&J Quality Policy, and regulatory requirements, focused on below items:

1.1.1.     Maintain supplier management procedure. Coordinate supplier management work, including the annual supplier audit plan. Conduct supplier management work, including supplier audit and supplier evaluation work, together with other functions.

1.1.2.     Material & Service Supplier Management
物料及服务供应商管理    Maintain supplier management procedure.
维护供应商的管理流程。    Lead and coordinate supplier annual audit plan, and follow up the audit action plan from supplier until closing.
负责供应商年度审计计划,和追踪供应商审计行动计划并关闭。    Conduct supplier management work with related team, including supplier audit and supplier evaluation work.
和相关部门合作完成供应商管理工作,包括供应商审核和供应商评估工作。    Be responsible for the quality review and approval quality related purchasing order in global purchasing system.

1.1.3.     Maintain and improve Non-J&J product and supplier quality management in JJMS.
维持和提高JJMS经营的非强生产品及供应商的质量管理    Conduct Non-J&J product supplier maintenance and management, such as periodic communications, change control, complaint handling, NC and CAPA follow-up.
进行供应商维护与管理,如定期联系,变更控制,投诉、不合格与异常的跟踪等。    Conduct Non-J&J product supplier audit, quality review and follow-up.
进行供应商的审核,质量评审与跟进。    Responsible for Non-J&J product routine inspection and release.
进行非强生产品供应商产品批次检验及放行。    Responsible for Non-J&J product document control, such as audit reports, change control records, batch release reports, etc.
维护非强生产品供应商的相关管理记录,如审核记录,变更记录,批放行记录等。    Provide COA and other relevant documents to sales.
帮助销售提供需要的合格报告及其他相关材料。    Support relevant groups with potential Non-J&J product supplier selection, evaluation and qualification.
支持相关部门合作筛选、评估及认证潜在非强生产品供应商。    Coordinate and responsible for new Non-J&J product supplier and product qualification process.
协调并负责新增非强生产品供应商及产品认证流程。    Following Non-J&J Product Control Procedure, responsible for procedure enhancement and compliance to J&J global and regional requirements.

1.1.4.     Lead internal QMS training matrix development in each quality related functions. Oversight the implementation of quality system training program throughout the organization.

1.1.5.     Maintain CSV procedure, coordinate with related functions for CSV of local developed GxP system.

1.2.   Other responsibilities defined in written procedures.

1.3.   Fulfill other tasks assigned.


1.1.   Bachelor Degree on pharmaceutical, medicine, medical device or related subjects. At least 5 years’ experience in quality compliance or related areas in medical device or pharmaceutical industries.

1.2.   Familiar with HA regulatory requirement for Medical Device in China, i.e. GMP, GSP, etc.

1.3.   Familiar with supplier management of Medical Device or Pharm, experience of Medical Device OEM supplier qualification and management is a plus.

1.4.   Good communication skills and leadership

1.5.   English fluent in reading, writing, oral and listening

1.6.   Familiar with routine operations of computer and software

2.      Skill Sets and/or Training and/or Certification for the Special Position

2.1.   Certification of ISO 13485/9001 Auditor/Lead Auditor
ISO 13485

2.2.   Ability to build collaboration and teamwork across functions.

Primary Location
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Quality (Eng)
Requisition ID