这是一个质量工程 （QE） 职位，需要个人在受监管环境中（例如 IVDD、医疗设备、制药、生物技术等）的风险管理、设计、验证、制造和上市后质量活动方面的知识/经验。 作为中国扩张项目的一部分，担任此角色的个人将负责协调质量工程 （QE） 工作流。
This is a Quality Engineering(QE) position that requires an individual knowledge/experience on risk, design, validation, manufacturing and post-marketing quality activities in a regulated environment, e.g., IVDD, Medical Device, Pharmaceutical, Biotech, etc. The individual in this role will be responsible for cooridanate the Quality Engineering(QE) workstream as part of the China expansion project.
职责领域 Areas of Responsibilties:： 1. 参与在验证和测试活动，如SVMP、验证方案和报告、执行流程/设备/设施/公用设施监测。 将与其他团队密切合作，确保流程及时获得适当资格/验证。
Participation as Quality Function representative on validation and qualification activities, such as validation protocol and report, execution monitoring for process, equipment, facilities and utilities of an IVD manufacturing facility to be built in China. Will work closely with the other project core team leads/functions to ensure that processes are appropriately qualified/validated in a timely manner.
Participate on design historical files transfer activities from sending site to receiving site; coordinating design review/manufacturing transfer review; reviewing and consultant for design change;
Participate on risk files transfer activities from sending site to receiving site and drafting activities for process, equipment, facility; reviewing and consultant quality case(nonconformity and change) risk analysis;
Coordinate on operational quality activities, such as nonconformity, deviation, change control, supplier quality management, product release; Ensure operational quality related activities meet company Quality Requirements.
Participate on establishment on process of post-market quality activities, such as complaint, Field Actions, Adverse Event, etc.
Other related projects or tasks assigned by superior or company
职能范围/内容 Dimension of Function/Volume： SHDM
Related functions in SHDM, e.g. Manufacturing, Technical Operations, Engineering and Quality Assurance; related departments in US site
教育和经验Education and Experience
A minimum of 3 years in medical device , biotechnology or pharmaceutical industry, with a Quality Engineer role. Majority experience in more than 2 areas and have some experience or knowledge are prefered.
• 能在至少 1 个领域独立处理质量工程任务，并能在其他领域在他人指导下进行工作的经验。
Individualy handling Quality Engineer activities in at least 1 areas and have experience of activities in other area with guideline from others.
Have product transfer experience or manufacturing establishment experiences are preferred.
本科学历。A minimum of a 4 year degree is required.