上海招聘

Job Description;

1. Work with sourcing team to select, evaluate potential suppliers, and qualify new suppliers for sourcing projects, and compile related English reports. 对于新采购项目，与采购部同事一起选择，评估和批准新供应商，并且编写相关英文报告。

2. Support on the communication with customers to understand the detailed or specific requirements at the beginning about suppliers’ capability and products’ compliance, communicate the requirement to suppliers, and push suppliers to do continuous improvement to meet the requirements. 参与前期与客户沟通了解其对于供应商和产品的具体符合性要求，与供应商沟通并推进供应商持续改进以满足客户要求。

3. Conduct supplier audit to assess the compliance and effectiveness of QMS of suppliers, and drive suppliers to improve the compliance and effectiveness of QMS, more focusing on development capability and compliance control. 熟悉ISO13485体系认证， 同时对供应商进行审核，评估其质量管理体系的符合性和有效性， 对于设计阶段评估尤为重要。

4. Compose various reports in bilingual after review, inspect or test the samples, review the documents submitted by suppliers, and conduct process capability study or process audit for manufacturing process of suppliers, to evaluate if the products of suppliers could meet the specification and all related quality requirement, including industry standards’, regulatory and customers’, and to evaluate if the manufacturing process of suppliers could consistently produce and supply the products of high quality. 评估，检验或测试供应商的产品样品，审阅供应商递交的文件， 并对供应商的生产过程进行过程能力研究和过程审核，以评估供应商的产品是否满足产品规格书以及相关的质量要求，包括行业标准要求，法规要求以及客户要求，供应商的生产过程是否能够持续稳定地生产并提供高质量的产品。并且编写相关英文报告。

5. Support on product compliance to ensure the product can meet design and regulations at the same time, meanwhile to ensure the verification result is positive from lab 参与新品验证工作以保证产品同时符合设计及法规要求，同时可以顺利通过实验室验证。

6. Establish the product inspection procedure or standard, train and instruct quality inspectors to inspect the products prior to products’ shipped out; and support to do pre-shipment inspection when the quality inspectors are not available. 建立产品检验程序或标准，培训和指导检验员对产品进行出货前检验，并在检验员短缺的情况下，亲自执行出货前检验。

7. Handle the customer complaints, work with suppliers to investigate the root cause, and drive suppliers to take necessary CAPs to improve the quality of products. 处理客户投诉，与供应商一起调查原因，推动供应商建立并执行必要的纠正预防措施来改善产品质量。

8. Manage the engineering change of suppliers, and ensure all engineering change can only be implemented after it’s approved by customers. 管理供应商的工程变更以确保所有的工程变更必须在得到客户批准后才能被执行。

9. Take the role to establish and maintain the QMS of our own company, including supporting cross countries’ systems, participating in the internal audit, drafting or updating documents of QMS, etc. 参与建立和维护质量管理体系，包括参与内审，编写和更新质量体系文件。

10. Participate in the continuous improvements activities on product quality, supply chain optimization and business process improvement. 参与产品质量持续改进活动，供应链优化和业务流程改进。

11. Participate in establishing and/or maintaining the database of products, regulatory or suppliers. 参与建立和维护产品、法规或供应商相关的数据库。

Requirements:

1. College degree is required, major in Science or Engineering discipline is preferred. 大学毕业，科学或工程专业。

2. Minimum 5 years’ QA working experience in the medical device, pharmaceutical or cosmetics industries. 至少在医疗器械、制药或化妆品等行业有5年以上的QA工作经验。

3. QC working experience in the medical device, pharmaceutical or cosmetics industries is also preferred. 有医疗器械、制药或化妆品等行业QC验货经验优先

4. Medical device regulatory knowledge for EU market, if more knowledge for USA and China is preferred. 熟悉欧盟的医疗器械法规要求及实务操作。

5. Sterilization knowledge (i.e. EO, Gamma, Steam) and process validation knowledge. 掌握一定的灭菌知识 （如，环氧乙烷、伽玛，蒸汽） 和过程确认知识。

6. Knowledge of standards or regulations of QMS (i.e. ISO9001 / ISO13485, US FDA QSR820, etc.), and have the experience of QMS audit. 掌握质量管理体系标准或法规知识 (比如：ISO9001 / ISO13485、 美国 FDA QSR820等)，有质量管理体系审核的经验。

7. Familiar with sampling inspection related standards, and have the experience of product inspection/test. 熟悉抽样检验相关标准，并有产品检验/测试经验。

8. Experience of medical device product registration is preferred. 有医疗器械产品注册经验会被优先考虑。

9. Full with energy, dynamic, and you are able to remain calm, and in control in high pressure situations. 充满活力，热情，能够保持冷静，控制情绪，抗压

10. Strong communication skill with different parties (Sourcing team, QC team, Suppliers, Oversea clients). 很强的沟通能力

11. Have strong technical background to analyze and deal with problems 较强的技术背景来分析解决问题

12. Fluent in Mandarin and English to a high level, and educationally中英文同样流利， 接受过较高的英文培训， 书面的， 口语的都应达到较高的水平

13. Self-motivator, Result driving, Team-player & Can-Do attitude. 能自我激励，结果导向、 团队合作精神与乐观进取的态度。

14. Proficient with Microsoft Word, PowerPoint, Project and Excel required. 熟悉各种办公软件。

15. Follow company policy and self-controlled during daily work 严格遵守公司规章制度， 自我约束， 自我管理

Honest， independently 诚实， 独立

The history of Nine United began in 1975 in a small town called Ringkobing on the western coast of Jutland, Denmark within the foundations of the Danish Clothing Company BESTSELLER. As Bestseller grew, new areas were explored and new business opportunities developed. The Nine United family began to evolve.

Nine United China was founded with the purpose of purchasing and supplying the Nine United family’s existing clients with retail and product solutions across multiple segments. It has since grown to provide complete purchasing and supply solutions for our network of international partners. Our client list now includes a wide variety of Europe & Asia’s largest retailers.
Another Nine United family member is HAY. HAY produces furniture and accessories for the global design market and Nine United China serves as a strong and valuable entrance to the Asian market, both as a link between HAY and its suppliers. HAY operates in the field between architecture and fashion, incorporating the statics from architecture, and the dynamics from fashion. Now, there are more brands we have: &tradition, Verpan, Frandsen.