职位描述：
Job description:
1、 熟悉或部分熟悉从低风险到高风险医疗器械产品的质量管理流程；
Familiar or Partially familiar with the quality assurance process of medical device from Low risk to High Risk;
2、 熟悉生产型企业的内部生产运作流程，能熟练使用各种质量改进的工具与技术进行质量分析；
Familiar with production process of manufacturing company, proficient with quality improve tool and quality problem analysis method;
3、 对医疗产品质量管理体系ISO13485, 21 CFR Part 820, MDSAP 质量体系认证有深入的了解，若有ISO13485内审员证书更佳；
Familiar with ISo13485，21 CFR Part 820, MDSAP medical device quality standard, qualified ISO13485 internal auditor is better;
4、 具有低风险到高风险医疗器械产品认证及注册的相关经验，负责协调和支持相关产品注册工作,包括但不仅限于：中国NMPA, 美国 FDA，欧洲及其他国际市场以及MDSAP涉及的市场。针对当地法规要求建立和维护相关程序，比如：客户投诉、上市后监督；产品标识等；
Familiar with and have the experience of the NMPA validation and registration of medical device from low risk to high risk, support the registration, including but not limited to NMPA, FDA, CE and other market. Set up the procedure based on the related regulatory requirement, for example, customer complaint, post market monitor, and product label;
5、帮助客户维护质量体系；
To help the customer to maintain the quality system if needed;
6、 帮助客户协调各部门进行持续质量改进活动；
To help the customer to co-operate with each functions to do quality improvement;
7、 帮助客户参与风险管理活动；
To help customer to participate in risk management;
8、帮助客户组织公司员工GMP知识方面的培训以及相关SOP的培训；
To help customer to carry on GMP and other SOP training.
任职资格：
Requirements:
1、 生物医药或医疗器械等相关专业，本科或以上学历；
bachelor degree or above of biological medicine or medical device;
2、 2-3年以上医药或医疗器械企业质量体系管理工作经验或相关咨询公司的经验；
more than 3 years’ working experience in QA or QC in Medical device or Pharmaceutical industry or relevant MD/IVD consulting Company
3、 熟悉医疗器械质量管理的法律法规；
Be familiar with medical device supervision regulation
4、 能编制质量管理体系文件，有内审员资格证书更佳；
Ability to set up the quality system, has internal auditor certificate is better;
5、 熟悉ISO13485，ISO14971，GMP等质量管理体系标准；
Be familiar with ISO13485, ISO14971, GMP quality management system
6、 能熟练应用计算机进行质量统计，对工序及产品质量进行统计完成报告书；
Proficient in MS Office SWs (Word, Excel, PPT, Project etc).
7、 有英文水平；
English in listening, speaking, reading and writing
8、 工作认真严谨，具有沟通、协调、组织管理能力和解决问题的能力；
Be strong and effective communicator with Corporate, and work under pressure, as well with the frequent trip with daily work.
9、具备高度的质量意识和工作责任心，良好团队合作精神，并能承受工作压力，并能接受现场审核出差需求。