生产质量保证工程师

JOB DESCRIPTION:

主要职责/Key Responsibilities：

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.

1. 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.

2. 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.

3. 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.

4. 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.

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

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

7. 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.

8. 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.

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

2. 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.

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

任职要求/Job Requirements：

1. 英语熟练Advanced level of English

2. 熟练掌握WORD, EXCEL, POWERPOINT等办公软件 Proficient in WORD, EXCEL, POWERPOINT and other office software

3. 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

4. 大学本科及以上学历Bachelor’s degree or above

5. 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
N/AIn specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION: ##LOCATION:
China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area

ADDITIONAL LOCATIONS: ##WORK SHIFT:
Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable