JOB SUMMARY
1. Participate ODM project, ensure product development process and deliverables can meet the requirements: regulatory, customer requirement and QMS.
参与项目开发过程，确保产品开发过程及输出满足相关法规和体系的要求
2. Design verification owner
负责设计验证。
3. Problem solving with six sigma or quality tools
合理利用质量或六西格玛工具解决问题
KEY RESPONSIBILITIES
1. Per Working closely with RD project team, define project quality plan, quality objectives and the deliverables at each stage.
与研发团队一起制定项目质量管理计划，规划项目各阶段的质量目标和交付。
2. Participate stage gate review and monitor Design control process, keep the integrity of design files and good design practice complied with Design control procedure and regulatory.
监控设计开发流程的执行和参加设计各阶段的评审，确保设计文档的完整性及开发活动符合设计开发程序和法规要求。
3. Conduct risk management activities such as DFMEA, MD Risk management.
主导研发过程中风险管理活动，比如潜在失效分析，医疗器械风险管理。
4. Conduct product verification plan based on design requirement.
根据设计要求制定产品设计验证计划。
5. Lead product verification test with in-house/outsourced lab resources, draft test report and analyze failure model with Quality/Six sigma.
主导设计验证，起草测试报告和合理利用质量或六西格玛工具进行失效分析。
6. Other tasks assigned by line manager.
直线经理分配的其它任务。
6. MINIMUM ACADEMIC REQUIREMENT
1. An automobile/ Communication / Engineering bachelor degree holder.
汽车，通信或相关工程本科学历
2. Min 5years experience in design quality assurance and product development environment.
至少有5年的产品研发质量管理和产品开发经验。
3. Have basic knowledge on design for six sigma, experienced Green belt or BB is big plus.
了解基本统计知识和DFSS, 有经验的绿带或黑带优先考虑。
4. Solid experience on automobile DFMEA。
精通汽车行业的设计潜在失效模式分析。
5. Excellent communication and people skills with the ability to see assignments through to completion with minimal oversight. Good communication and influencing skills to work across the functional team.
优秀的沟通和人际交往能力，能够在积极主动完成任务，并能够跨部门合作。
6. Good communication skill in both English and Chinese. CET-6 or above is preferred.
良好的中英文沟通能力。英文CET-6及以上优先。