JOB DESCRIPTION SUMMARY:
负责检验员团队的日常管理，根据生产计划安排检验工作并监督和维护整个检验员团队，以保证所有的检验工作的准确有效。
Responsible for the daily management of the inspector team, arrange the inspection work according to the production plan and supervise and maintain the whole inspector team to ensure the accuracy and effectiveness of all inspection work.
KEY RESPONSIBILITIES:
- 负责检验员团队的人员管理并根据生产计划安排检验工作；
- Responsible for the quality inspectors team management and arrange inspection work according to the production plan;
- 负责建立检验员团队的人员操作技能培训及发展计划，并监督实施及跟踪管理；
- Responsible for establishing the training and development plan for the inspector team, and supervising the implementation and follow-up Control Budget and expense.
- 负责生产线相关质量记录的收集、整理和存档。
- Be Responsible for collection, collation and archiving of related quality records for production line。
- 负责质量管控工作，包括制定或者更新质量文件，完成检验方法验证，负责验证方案、验证报告和偏差分析报告的审核
- Responsible for QA activities, including establish/update quality procedures; finish test method validation ; review validation protocol, report and deviations.
- 负责组织不合格和偏差的原因调查及不合品处置，参与制定纠正预防措施及并跟踪措施的落实直至NCR关闭。
- Responsible for NCR and plant deviation investigation, corrective action implementation, actions tracking till NCR close.
EXPERIENCE & EDUCATION:
- Minimum Bachelor Degree required. 本科或以上学历毕业；
- Minimum 5 years working experience in Quality. QA工作经验5年以上；
- Familiar with ISO13485 and Medical Device GMP. 熟悉ISO13485质量管理体系，熟悉GMP要求；
- Familiar with FMEA, Control plan, MSA. 熟悉FMEA, Control plan, MSA；
KNOWLEDGE, SKILLS AND ABILITIES:
- Good communication skills and learning capabilities. 良好的沟通技巧和学习能力；
- Familiar with office software. 电脑办公软件应用熟练；
