工作职责
1.1 Assist Quality Manager in quality managementof projects under ISO9001 system and work with project team to confirm allactivities and related documents meet the quality system requirements of ISO9001 globally and locally in China of Johnson & Johnson. 辅助质量经理对于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。
1.2 Be responsible for the storage and arrangement of process documents and project documents. 负责流程文件及项目文件的整理及保存。
1.3 Assist Quality Manager in confirming thequality of the product design: ensure software design meets best practices andstandards, review and evaluate software design documentation, and provide feedbackand recommendations for optimization. 辅助质量经理确认产品设计的质量:确保软件设计符合最佳实践和标准,审查和评估软件设计文档,并提供优化反馈和建议。
1.4 Manage employee training programs and JD andmaintain records. 管理员工培训计划及JD, 并保存相关的记录。
1.5 Support DHF document control and processtraining 支持 DHF文件控制和流程培训等工作
任职要求
2.1 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。
2.2 Quality management experience of product design and development process.产品研发过程质量管理经验。
2.3 Ability to build collaboration and teamwork across functions.有能力跨部门进行合作与团队工作。
2.4 Good communication skills and leadership.良好的沟通和领导能力。
2.5 English fluent in reading, writing, speaking and listening.流畅的英文听说读写能力。
2.6 Familiar with routine operations of computer and software. 熟练操作计算机常用功能。