一、岗位职责：
1、负责基地新产品质量策划，配合研发技术部，进行新产品/新项目工艺确认。Take response new product quality planning, cooperating with the R&D& technology department, to carry out process V&V for new products/new projects.
2、负责审核新产品质量控制计划、FMEA、作业指导书等文件中与质量控制有关的项目； Responsible for the new product quality control plan, FMEA, work instructions and other documents related to quality control items
3、根据产品测试/监控数据分析，主动提出改进建议并推动持续改进; Proactively raise improvement suggestion and drive continuous improvement based on product testing/monitor data analysis.
4、主导质量异常及产品投诉的调查及改进；Lead quality issues and product customer complaint investigation and improvement.
5、负责项目报告的评审，确保内容符合所有适用的质量体系要求和产品要求Responsible review for project reports, ensures the content meets all applicable quality system requirements and product requirements.；
6、主导过程风险管理活动，包括推动风险管理档案的建立、审查和更新。Lead process risk management activities including driving the creation, review and update of risk management files.
7、负责产品上市后活动，包括产品投诉、忠告性通知/产品信息告知、不良事件报告（含定期风险评价报告）、召回等。Responsible for post-market activities, including product complaints, advisory notices/product information notification, adverse event reports (including periodic risk assessment reports), recalls, etc.
8、完成上级主管或公司交付的其他相关工作；other related projects or tasks assigned by supervisor or the company.
二、任职资格
1、3年或以上医疗器械有源产品相关工作经验。 years or more of relevant work experience in medical active products
2、法规合规知识： ISO13485; ISO14971; GMP,QSR 820.。。。等。Regulatory compliance knowledge: ISO13485; ISO14971; GMP, QSR 820.... etc.
3、数据统计分析和流程优化技能。Statistical data analysis and process improvement skills
4、具有良好的问题解决技能，能够分清多任务项目的轻重缓急，在压力下可以良好工作。Good problem solving skills, able to prioritise multi-tasking projects and work well under pressure.
5、具备良好的团队合作和沟通能力，有强烈的探索精神，善于学习、工作认真负责Good teamwork and communication skills, strong spirit of discovery, good at learning, work diligently and accountable.
三、教育背景要求：
理工科背景（电子，机电一体化）本科或以上，英语四级，六级； 需要具备一定的口语和良好的英文书写能力。
Bachelor's Degree or above in Science and Engineering (Electrical Engineering, Electromechanical Integration) background, English Level- 4, 6 grade； Fair oral and Good written English is required.
四、公司基本情况
单双休（早8点，晚5点），法定节假日全放，能接受加班；
入职就缴纳五险一金，有餐补，三节福利，在职体检，定期聚餐等，工作氛围好，公司环境好，领导和蔼可亲，公司发展稳定。