MQA Engineer

JOB DESCRIPTION:

岗位职责

1.跟踪维护和分析产品批记录与跨团队合作寻找批记录的改进机会协调成品放行Track maintain and analyze the batch record cooperate with cross team for the improvement opportunity of batch record and coordinate for finished product release.

2.监控生产过程及时发现生产过程中的任何问题并与跨职能部门沟通从质量角度解决问题确保执行的合规状态To monitor the manufacturing process timely catching up any issues during production and communicate with cross functions for the trouble shooting from quality standpoint making sure the compliance status of execution.

3.对生产进行在线质量管理并根据实际生产情况制定适当的程序来指导新问题On line quality management for production and develop proper procedure to guide the new issues according to actual production.

4.与计划部门生产部门包装部门等相关部门协同一起解决问题Coordinate with cross departments for the trouble shooting like work order manufacturing packaging and so on.

5.并且单独这些问题评估对成品的影响并成为决策者Meanwhile individually evaluate the impact of the finished product and be a decision maker.

6.承担其他质量保证职责Undertake other quality assurance responsibilities.

7.执行外部文件评估Perform external document assessment.

8.在线监控生产车间GMP (良好生产管理规范)支持并跟踪改进Online monitoring for manufacturing shop floor GMP supporting & following the improvement.

9.独立观察问题并使用RCA和5WHY等质量工具解决问题Observe issues independently and trouble-shooting for them by using quality tools like RCA and 5WHY.

10.对新员工进行培训Provide training to new comer.

11.对产品批记录审核和产品放行进行内部协调Conduct internal coordination for batch record review and batch release.

12.完成上级临时交办的其他任务Timely handling of the work assigned by supervisor.

任职资格

1.资格证书/Certificate

无要求No Requirements

2.外语技能/Foreign Language Skills

英语熟练Advanced level of English

3.计算机软件技能Software Skills

熟练掌握WORD EXCEL POWERPOINT等办公软件Proficient in WORD EXCEL

POWERPOINT and other office software

4.工作经验或专业背景/Work Experience or Professional Background

3年以上质量管理工作经验优先Preference will be given to those with more

than 3 years of experience in quality management

5.教育背景/Education Background

大学本科及以上学历Bachelors degree or above

6.其它要求/Others

熟悉国内外医疗器械监管环境Expertise with the domestic and international

medical device regulatory environment

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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