职位概要(Job summary):
新项目开发的品质保证。
Quality assurance for new project quality development.
工作职责(Responsibilities):
1. 制定新项目导入的品质保证和合规性要求，并审阅和修订相关的质量协议和合规性声明及产品注册要求；
Set the quality assurance and regulatory compliance request for new project transfer, review and revision the related quality agreement and compliance certification and registration request.
2. 参与新产品过程开发，识别各过程中的风险并制定风险控制措施；
Take part in new process development for new product, identify the risks from the new process and define proper activities to control the risks.
3. 参与制定过程验证主计划并审核OQ和PQ，确保过程风险点被有效验证；
Participate to create VMP (validation Master Plan), and review OQ (Operation Qualification) and PQ (Performance Qualification) to ensure all risks be validated effectively.
4. 制定产品外观标准并与客户达成一致；
To align cosmetic criteria with customer.
5. 建立产品测试方法并实施TMV (Test Method Validation)；
Establish specific test method for product and implement TMV.
6. 建立适当的车间环境及微生物控制流程以满足产品灭菌要求；
Establish control procedure for new product to meet sterilization requirement.
7. 建立过程控制计划以及相关检验WI；
Create process control plan and related work instruction for inspection.
8. 建立物料可接受标准，并完成物料检验WI；
Align material acceptance criteria, and establish work instruction for incoming material.
9. 评估供应商的测试方法和验证结果；
Align test/inspection method with vendor, such as tooling selection, TMV protocol, etc.
10. 确认打样物料的符合性。
Verify if incoming materials meet the requirements, which are for prototype sample building.
任职资格(Qualification) :
1. 本科及以上学历，6年以上医疗器械品质保证工作经历；
Above Bachelor degree, and more than 6 years quality assurance work experience for medical device;
2. 熟悉新产品开发流程及基础的品质工具(SPC/ MSA/ PFMEA/ Control Plan/ APQP/ PPAP)；
Familiar with new product development procedure and basic quality tools.
3. 英语能作为工作语言；
English can be used for communicating as normal.