上海招聘

职位描述：

Supplier Interactions:

？ Conduct supplier audit to assess the compliance and effectiveness of QMS of suppliers, and drive suppliers to improve the compliance and effectiveness of QMS.

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。

？ Establish the product inspection procedure or standard, train and instruct quality inspectors to inspect the products prior to products shipped out; and do product pre-shipment inspection by oneself when the resource of quality inspectors is not enough.

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。

？ Work with sourcing to select, evaluate potential suppliers, and qualify new suppliers for sourcing projects. And write or compile related report in English.

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。

？ Work with sourcing and logistics to evaluate the performance of suppliers and push supplier to improve the performance.

与采购部和物流部同事一起评估供应商的绩效，并推动供应商改进绩效。

？ Handle the customer complaints, work with suppliers to investigate the root cause, and drive suppliers to take necessary CAPAs 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。

？ Manage the engineering change of suppliers, and ensure all engineering change can only be implemented after it’s approved by Nubenco and 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Nubenco和客户批准后才能被执行。

？ Manage the team of quality inspectors; coordinate the activities of all product inspection, including pre-shipment inspection and product sterility testing.

管理质量检验员队伍；协调所有产品检验的活动，包括装运前检验和产品的无菌检验。

？ Select, evaluate and qualify 3rd party contract sterilizer, and conduct annual surveillance audit for 3rd party contract sterilizer.

选择、评估和符合第三方的消毒设备，并对第三方灭菌设备进行年度监督审核。

Headquarters Interactions:

？ Maintain active communicate in English with customers to understand the requirement for suppliers and products, communicate the requirement to suppliers, and push suppliers to do continuous improvement to meet the requirements.

主动与客户沟通了解其对于供应商和产品的要求，与供应商沟通并推进供应商持续改进以满足客户要求。

？ Participate in the continuous improvements activities of Nubenco about the product quality and/or cost, and business process improvement.

参与Nubenco的产品质量或成本持续改进活动和业务流程改进。

？ Ensure oneself and subordinate with high level of compliance with company’s code of honor and conduct ourselves with the highest standards of professional ethics, honesty and integrity.

确保自己和下属具有高水平的职业道德，诚实正直的最高标准。

？ Participate in establishing and/or maintaining the database of products, regulatory or suppliers.

参与建立和维护产品、法规或供应商的相关数据库。

？ Participate in the establishment and maintenance of QMS of Nubenco, including participating in the internal audit, drafting or updating documents of QMS, etc.

参与建立和维护Nubenco的质量管理体系，包括参与内审，编写和更新质量体系文件。

？ Collect the data of KPI and provide KPI report to general manager monthly.

收集KPI的数据，并每月向总经理提供KPI报告。

？ 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。

？ Maintain written and oral communicate various questions received from customers about the products or supplier quality, and support customers to improve the quality of products and/or supplier quality management.

回答客户的关于产品质量或供应商质量的问题，支持客户改进产品质量以及/或改进供应商质量管理。

Qualifications:
College degree is required, major in Science or Engineering discipline is preferred;

大学毕业，科学或工程专业。

？ Minimum 8 years’ QA or RA working experience in the medical device or pharmaceutical industries.

至少在医疗器械或制药行业有8年以上的QA或RA工作经验。

？ Knowledge of standards or regulations of QMS (i.e. ISO9001 / ISO13485, US FDA QSR820, etc.), and have the solid experience of leading a 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。

？ Familiar with sampling inspection related standards (i.e. ANSI Z1.4, GB2828, etc.), and have the solid experience of product inspection/test, including establishing inspection procedure/standard.

熟悉抽样检验相关标准 （比如：ANSI Z1.4、 GB2828 等），并有产品检验/测试经验。

？ Quality tools knowledge and using skill, including SPC, FMEA, MSA, DOE, etc.

质量工具知识和使用技能，包括SPC、FMEA、MSA、DOE等。

？ Wealthy 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。

？ Fluent in English - both written and oral required.

英文听说读写流利。

？ Proficient with Microsoft Word, PowerPoint, Project and Excel required.

熟悉各种办公软件。

？ Medical device regulatory knowledge including USA, EU and China product registration requirements.

掌握一定的中国，欧洲和美国的医疗器械法规知识。
Position Type/Expected Hours of Work
Office standard hours of work are Monday through Friday, 8:00 a.m. to 5:30 p.m. Frequent domestic travel may require working weekends, as needed.Travel
Travel is expected to be a minimum of 50%, with virtually all travel to be in country.

Additional Eligibility Qualifications:

· Excellent written and oral communication skills.

· Demonstrated leadership ability, team management, and interpersonal skills.

· Excellent analytical and abstract reasoning skills, plus excellent organization skills.

· Flexible and a self-starter; able to multi-task while also being highly detail-oriented.

 我司为美国公司设立在亚洲地区的采购公司，于2002年成立，目前国内有近三十家供应厂商，并且有着良好的合作关系！我司产品主要销往南美洲、欧洲、非洲及中东地区！我们愿意在互惠互利的基础上与有实力，重诚信的生产厂家建立长期合作关系！我们始终坚持用户至上、用心服务于客户，坚持用自己的服务去打动客户，欢迎各位来参观指导工作。