דרושים Sr Regulatory Engineer ב-Philips ב-China, Bao'an District

Provide appropriate global regulatory strategy and planning for new product introductions and product change; ensure timely and well-organized registrations activities; Provide guidance on risk assessment, clinical evaluation and required corrective...

Balance current and future stakeholder/business needs and translates these into architectural and technological choices. Deliver high quality solutions or products, by meeting user and business requirements and managing technical complexity....

Develop and execute a comprehensive test plan with a systematic Quality Assurance methodology. Performs software testing (automated or manual) within the systems/agile/scrum team throughout the whole development cycle ensuring built-in...

独立处理内部及客户反馈的品质问题，有效降低客户拒收比率；跟进新项目转产过程的品质需求， 确保所有的新项目顺利转产且符合法规和品质要求； 确保新项目顺利转产和转产后产品质量的持续改善，确保生产模具和设备完成验证。. 协调新产品转生产前所有的品质要求已达成；. 协调产品在注册前后的各种品质需求的达成及品质系统的完善；. 协调实施产品风险管理和风险分析，建立产品风险管理文档，确保产品质量符合客户要求的同时，产品的任何风险得到有效预防和控制，以确保产品安全、有效和高度的可靠性；. 协调过程更改并确保整个更改过程的文件和样板正确更改；. 完成相关的过程确认和特殊工序和设备的验证，确保生产正常及顺利转产；确保生产过程符合法规要求；. 完成新项目的量测方法和量测的重复性和再现性确认；. 推进过程改善行动，确保成品内部拒收率达成目标;. 执行市场反馈分析，确保主要产品的退货率持续降低；. 提供技术支持和方法，协助生产线有效控制品质并持续降低品质控制成本；. 独立处理内部及客户反馈的品质问题，有效及时处理客户投诉，并确保措施的有效性。. 学历: 本科或以上学历，理工科优先. 工作经验: 0-4年品质工作经验. 能力和技能: 熟悉ISO13485标准& FDA 21 CFR 820 QSR 法规,了解行业内不同区域品质体系相关的法规要求，有一定品质体系建立维护经验；. 熟悉并掌握QC7大手法，并能使用不同的品质控制工具。. 能阅读和书写英文；....

Lead Quality engineers to improve product manufacture process and provide technical support to control product quality meet customer requirement. Take part in process improvement activity to control Finished Goods internal...

Together with the program manager and category lead you will translate the long term business strategy into consumer benefit driven propositions for the local and global market, based on existing...

To lead a software team participate in a project to realize software functions and quality requirements, collaborate with cross-functional team to meet project target;. To build and optimize software platform...