招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
General Function/通用职能
Take part in quality system implementation and projects process quality control.
参与质量体系实施和项目实施过程质量控制。
Major Responsibilities/主要职责
Quality planning, validation and control for new projects
质量策划，新项目的验证和控制
1. Review the customer Specification, drawing and special requirement for new project.
审核新项目的客户规范、图纸和特殊要求。
2. Design the validation protocol (IQ/OQ/PQ) together with the project team members.
与新项目团队成员一起设计验证方案（安装确认、 运行确认、性能确认)。
3. Work out the related document for Medical project, such as DMR, DHR, FMEA, Control plan etc.
制定医疗项目的相关文件如：DMR,DHR,FMEA,控制计划等。
4. Summarize the validation report together with the project team members.
与项目团队成员一起总结验证报告。
5. Design quality plan, inspection instruction, and test method for new project.
为新项目设计质量计划、检验指导书和检测方法。
6. Training for inspector/operator for quality plan, inspection instruction and test method.
为检验员和作业员进行质量计划、检验指导书和测试方法培训。
7. ECN execution.
执行工程变更。
8. Response for the engineer change order and engineer change notice.
响应工程变更工单和工程变更通知。
9. Customer complain responding, corrective action follow up.
客户抱怨回复，纠正措施跟踪。
10. Take part in quality system implementation, maintenance.
参与质量体系的实施和维护。
11. Collect process quality data and quality trend analysis.
收集过程质量数据和质量趋势分析。
?At least 3 years of validation experience in medical device industry.
至少3年医疗器械行业验证经验。
?Knowledge in GMP
良好的GMP知识
?Be familiar with validation approach (IQ/OQ/PQ).
熟悉验证方法（安装确认、 运行确认、性能确认）。
?Be familiar with Molding, assembly process, including welding, hot stamping, heat staking, and automation, sterilization is preferred.
熟悉注塑、组装过程，包括焊接、热转印、热熔和自动化，熟知灭菌过程优先。
?Be familiar with quality tools and Minitab data analysis.
熟悉质量工具和Minitab数据分析。
?Be familiar with ISO9001, ISO13485, CFR820 and CFDA regulation is preferred.
熟悉ISO9001, ISO13485, CFR820，和中国药监局的法律法规优先。
?Good English skill both in written and oral.
熟练的英语口语和书写沟通能力。
?Good communication and team work spirit.
良好的沟通能力和团队合作精神。
求职提醒：求职过程请勿缴纳费用，谨防诈骗！若信息不实请举报。
