职位： 医疗器械-质量高级工程师

1. 有海外工作、学习经历
2. 本科其以上学历，8年以上相关工作经验
3. 3个月内到位

职位描述：
Job description:
1、熟悉三类医疗器械产品的质量管理流程；
Familiar with the quality assurance process of medical device class III;
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质量体系认证有深入的了解，具有ISO13485内审员证书； Familiar with ISo13485 medical device quality standard, qualified ISO13485 internal auditor;
4、具有三类医疗器械产品SFDA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SFDA, 美国 FDA，欧洲及其他国际市场。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 SFDA validation and registration of medical device class III, support the registration, including but not limited to SFDA, 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、维护质量体系；
To maintain the quality system;
6、协调各部门进行持续质量改进活动；
To co-operate with each functions to do quality improvement;
7、参与风险管理活动；
To participate in risk management;
8、负责内部和外部质量审核，主持每年的内部审核及管理评审，并对不合格项的纠正预防措施进行跟踪。负责检查和评估质量体系运营状况，保证管理持续改善和质量体系有效运行；
To responsible for internal and external quality audit; responsible for the internal audit and management review, follow the corrective action and preventive action for non-conformity. Check and review the operational status, to ensure the continuous improvement;
9、组织公司员工GMP知识方面的培训以及相关SOP的培训；
To carry on GMP and other SOP training.

任职资格：
Requirements:
1、生物医药或医疗器械相关专业，本科以上学历；
have bachelor degree or above of biological medicine or medical device;
2、3年以上医药或医疗器械企业质量体系管理工作经验； more than 3 years’ working experience in QA or QC in Medical device or Pharmaceutical industry
3、熟悉医疗器械质量管理的法律法规；
To 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；
Ability to set up the quality system, has internal auditor certificate;
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、有一定的英文水平； 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,
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。