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:
支持质量经理按照ISO13485J&J质量方针和法规要求维持和提高JJMS质量体系的符合性,侧重在以下方面:

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.
维护供应商管理流程,与其他相关部门一起协调供应商管理工作,包括供应商审核计划、供应商审核与供应商评估。

1.1.2.     Material & Service Supplier Management
物料及服务供应商管理

1.1.2.1.    Maintain supplier management procedure.
维护供应商的管理流程。

1.1.2.2.    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。

1.1.2.3.    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。

1.1.2.4.    Be responsible for the quality review and approval quality related purchasing order in global purchasing system.
负责在全球采购系统中质量相关采购订单的质量审批工作。

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

1.1.3.1.    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。

1.1.3.2.    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。

1.1.3.3.    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。

1.1.3.4.    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。

1.1.3.5.    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。

1.1.3.6.    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。

1.1.3.7.    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。

1.1.3.8.    Following Non-J&J Product Control Procedure, responsible for procedure enhancement and compliance to J&J global and regional requirements.
执行非J&J产品控制流程,负责流程优化并确保流程满足强生总部及区域要求。

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.
领导各质量相关部门进行QMS培训矩阵的开发,监督组织内部质量体系培训项目的完成情况。

1.1.5.     Maintain CSV procedure, coordinate with related functions for CSV of local developed GxP system.
维护CSV程序,协调相关部门完成本地开发的GxP系统的CSV

1.2.   Other responsibilities defined in written procedures.
流程中规定的其它职责。

1.3.   Fulfill other tasks assigned.
其它指定的工作任务。


Qualifications

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.
药学,医学,医疗器械相关专业本科学历。至少5年的医疗器械或药厂质量体系符合性或相关领域的经验。

1.2.   Familiar with HA regulatory requirement for Medical Device in China, i.e. GMP, GSP, etc.
熟悉中国医疗器械法规的要求,如GMPGSP等。

1.3.   Familiar with supplier management of Medical Device or Pharm, experience of Medical Device OEM supplier qualification and management is a plus.
熟悉医疗器械或药品供应商管理,有医疗器械OEM供应商审核和管理经验更佳。

1.4.   Good communication skills and leadership
良好的沟通和领导能力

1.5.   English fluent in reading, writing, oral and listening
流畅的英文听说读写能力

1.6.   Familiar with routine operations of computer and software
熟练操作计算机常用功能

2.      Skill Sets and/or Training and/or Certification for the Special Position
特殊岗位的技能和/或培训和/或证书要求

2.1.   Certification of ISO 13485/9001 Auditor/Lead Auditor
ISO 13485
9001的审核员/主任审核员资质

2.2.   Ability to build collaboration and teamwork across functions.
有能力跨部门进行合作与团队工作。


Primary Location
China-Shanghai-Shanghai
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Quality (Eng)
Requisition ID
1805658083W