1.Principal Duties and Responsibilities (General Summary , essential functions and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
1.1Quality Management for Digital projects base on ISO9001, Works with project team to confirm that all quality related activities and documents meet the quality requirements of ISO9001 both global and China of Johnson & Johnson.
对于ISO9001体系下的项目进行质量管理，与项目组协作确认所有活动及相关文档满足强生全球和中国本地的 ISO9001的质量体系要求。
1.2Responsible for ensuring quality of the product requirements analysis: ensuring that the product Backlog meets the product requirements specifications, and working closely with the Agile Leader and the development team to resolve requirements related issues and questions.
负责保证需求分析的质量：确保产品Backlog符合产品需求说明，同时，与敏捷主管和开发团队密切合作，解决需求相关的问题和疑问。
1.3Responsible for ensuring the quality of the design: ensuring that the software design conforms to best practices and standards, reviewing and evaluating the software design documentation, and providing feedback and recommendations for optimization.
负责保证设计的质量：确保软件设计符合实践和标准，审查和评估软件设计文档，并提供优化反馈和建议。
1.4Responsible for ensuring the quality of testing: Provide recommendations and confirmation of test access and approval for different phases of software, review test plans, test scenarios, test scripts/use cases, etc., take measures to drive the resolution of test issues/defects, and ensure the quality of test reports.
负责保证测试的质量：提供软件不同阶段的测试准入、准出的建议和确认，评审测试计划、测试方案、测试脚本/用例等，采取措施推动解决测试问题/缺陷，并确保测试报告的质量。
1.5Responsible for Digital product supporting as QA from Gate C to P5 base on ISO9001 Requirement.
基于ISO9001要求负责数字化产品从立项到产品上市的 QA职责。
1.6Support DHF document control and process training
支持 DHF文件控制和流程培训等工作。

Other responsibilities defined in written procedures.
流程中规定的其它职责。
基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）
Master’s or bachelor’s degree on pharmaceutical, medicine, software engineer, mechanical automation or related subjects. At least 2 years’ experience in medical device, pharmaceutical, or electrical industry in well-know enterprise.
药学，医学，软件工程，机械自动化相关专业本科或硕士学历。至少2年的知名医疗器械、制药或电子企业质量管理的工作经验
Quality management experience of product design and development process
产品研发过程质量管理经验
Ability to build collaboration and teamwork across functions
有能力跨部门进行合作与团队工作
Good communication skills and leadership
良好的沟通和领导能力
English fluent in reading, writing, speaking and listening
流畅的英文听说读写能力
Familiar with routine operations of computer and software
熟练操作计算机常用功能