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. 大专以上学历,3年以上品质保证工作经历;
College above, and more than 3 years quality assurance related work experience;
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。
3096 0412-1|171 8491 1067 01English can be used for communicating as normal.
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