Supervisor, Quality operations

1. 产品放行 Product Release

1. 根据发运计划 ，负责协调相关部门和人员 ，安排产品放行工作

Responsible for coordinating the product release with the relevant department and individuals in terms of the shipment schedule

1. 协调相关人员完成检测数据和记录的复核，确保产品放行满足放行条件

Oversight the relevant people to review the testing data and records, ensure the product release in compliance with the specified requirements

1. 负责按计划完成放行，确保完成部门放行指标

Responsible for releasing the product in terms of shipping plan to ensure achievement of functional service KPI

1. 在产品放行阶段，发现不符合，协调相关进行调查并评估风险

Coordinate the investigation and conduct the risk assessment for the nonconformance discovered at the product release stage

1. 不符合事件处理 Handling NCR/CAPA

1. 支持不符合事件的发起、影响范围、围堵措施

Support initiating the nonconformance, determining the bracket and containment

1. 支持不符合基础事件报告的批准和产品/物料处置

Support the approval of base ER and product/material disposition

1. 协调生产过程中产品/物料的不符合事件的处理 ，包括发起 、界定、围堵以及纠正

Coordinate to handle the nonconformance related with product/material happened during the course of production, including initiation, bounding, containment and correction

1. 参与不符合事件的调查和审核报告，对纠正预防措施的实施和有效性进行确认

Participate in the investigation and review of report, and verify the execution of CAPA and action effectiveness

1. 如需要，根据 ANSI ASQ Z1.4/Z1.9 制定取样方案

Work out the sampling plan according to ANSI ASQ Z1.4/Z1.9 if needed

1. 支持在线 QA 的日常工作 Support on-line QA routine work

1. 对生产现场进行监督 ，有效的驱动质量改进和建立有效的现场质量文化

Provide quality oversight on operation floors production, drive field quality improvement and shape heathy quality culture at operational field

1. 及时完成批生产记录的发放和评审

Prepare and distribute batch records and conduct DHR review in a timely manner

1. 生产和验证支持 Manufacturing and validation Supporting

1. 与生产同事探讨改善操作流程提高效率和产品质量

       Interact with production personnel to discuss better operational procedures for elevating efficiency and product quality.

1. 负责自己的培训和为本岗位新进员工提供相应的质量体系培训

Accept responsibility of training and provide the training for new employees for this position as trainer

1. 通过系统收集质量数据和采用合适分析方法分析数据支持产品/过程改进（ 例如：报废、不合格品）,改善产品设计

Assist product/Process improvement efforts（e.g. scrap, nonconforming product) by systematically gathering quality metric data and by assisting in the appropriated analysis methods to enhance sustaining product design

1. 负责年度产品质量趋势评审的工作， 有效的驱动质量改进

Responsible for annual product review program, by which to drive product and process quality improvement

1. 审计支持和项目管理 Audit Assisting and Project Management

1. 作为产品放行的主题专家支持内部和外部审计

Support internal & external audit as product release SME

1. 支持相关部门的项目

Support the project led by the relevant department

1. 确保项目按计划完成并达成预期结果

Accountable for project completion as planned and achievement of pre-established goal

1. 与项目团队和跨部门团队讨论与质量范畴内的事宜并提供意见

Interact with Project Teams and cross-functional groups to discuss the event related with quality and provide the suggestion from the perspective of quality

1. 文件控制 Document control

1. 负责文件管理系统的运行和日常维护。

Responsible for the operation and maintenance of document management system.

1. 确保相关工厂程序符现行法规及公司政策。

Ensure relevant procedure to comply with current regulations and company and division procedures.

1. 负责文件控制中心的管理，确保文件保存完整、易于查阅。

Responsible for the management of document center to ensure document integrity and easy-to-access.

1. 负责质量文件及记录的存档管理。

Responsible for retention and of quality documentation and record.

1. 投诉处理 Complaint Control

1. 维护投诉和不良事件处理流程，确保程序严格执行

Maintain complaint handling process and AE process, and ensure procedure is executed as procedure.

1. 支持杭州工厂的投诉CIE项目。

Support CIE project in Hangzhou site.

1. 其他 Others

1. 维护部门质量数据和起草趋势报告

Maintain the data for quality metrics and draft the trend report

1. 激励和辅导下属完成部门目标，确认适当的培训需求，实施培训计划。

Incent and coach the subordinate to complete the target of department and confirm the appropriate the training needs and implement the training plan.

1. 直线经理指定的其它工作

Complete the temporary tasks assigned by line manger

1. 必备技能 : ESSENTIAL SKILLS AND ABILITIES:

1. GMP工作经验和ISO13485和其他法规要求

Experience working in a GMP environment and knowledge of ISO13485 and other international regulatory requirements

1. 良好的组织协调能力，和沟通能力。

Good organizing and coordinating skill, good communication and interpersonal skills.

1. 熟练运用质量工具进行数据统计和分析。

Familiar with quality tools (like Minitab, Cpk) to perform data stat. and analysis.

1. 良好的英语书写能力和基本的口语交流能力

Smooth in writing and basic communication in oral in English

1. 熟悉不符合事件处理流程和产品放行流程。

Familiar with nonconformance handle process and product release

1. 了解变更控制和验证基本要求，最好有一定的内审经验。

Understand the essential elements of change control and validation, and preference given for internal audit experience

1. 有一定逻辑思维能力

Logic thinking