岗位职责
Position Requirements
1、确保公司运作符合医疗行业相关法律法规要求。Ensure company operations comply with medical industrial laws and requirements.
2、负责对所有原材料，外购外协件进料检验，按控制计划对过程进行检验、测试和监控；Be responsible for all raw materials and parts outside for quality checking, And check, test and monitor all processes base on the control plan.
3、负责成品的最终出厂核对和测试，负责对供货商质量能力进行调查、评估，确定合格供方。Be responsible for finished goods checking and testing. Also be responsible for supplier management via investigating and evaluating, so as to get qualified suppliers.
4、负责对客户回馈的调查、处理，并做出相应的改善应对措施并督促执行；Be responsible for handle customers’ feedback base on investigation. And make up the action plan related, then execution.
5、分析汇总质量问题，协助生产部、工艺部门解决产品生产中的重大质量问题；Analysis and collect the quality problems, and assist Production, Process Departments to solve serious quality issues.
6、参与新产品项目开发，实施设计验证，协助设计确认，设计转移，设计变更；Be Involved in new product program management, implementing design verification, and to assist design confirmation, variation.
7、组织公司相关设施设备的验证、仪器设备校准工作；Be responsible for organizing company facilities and equipments verification.
8、组织产品不良事件的收集与报告；Be responsible for collecting and reporting on non-compliance cases base on quality system.
9、参与风险管理工作，协助风险分析，编写风险管理报告；Be involved in risk management, and to assist risk analysis, making up risk management report.
10、迎审各客户、监管机构、认证机构的审核工作；Be responsible for all kinds of audits, which are from customers、monitoring organizations and verification organizations
11、确保ISO13485、CGMP、GMP等体系在部门的有效实施；Ensuring the ISO13485、CGMP and GMP systems run effectively through the departments.
12、完成上级领导临时交办的其他工作。The other task that the superior assigned.
任职资格：Qualifications
1、大学本科以上学历，相关专业背景；Bachelor degree or above education with related majors
2、8年以上医疗器械质量管理经验或相关工作经验；8 years’ experience in medical devices quality management, or related working experience.
3、曾参与或主导ISO13485体系、CGMP和GSP体系认证专案；With ISO13485 , CGMP, GSP system verification experience, involved or play a leader role in the program
4、熟悉6SIGMA及相关统计分析工具，如：SPC、Minitab等；Be familiar with 6sigma and related analysis tools, such as SPC, Minitab.
5、持有ISO13485内审员证书，且具备丰富的内审及外审经验；be the holder of ISO13485 internal auditor certification, and with rich experience in internal and external audits.
6、具有一定的项目管理经验及客户验厂经验；With rich experience in program management and customer audits.
3164 0275-0|171 3603 5889 667、英语读写流利。Fluently English in written and reading is a must.

年龄要求：28-45岁