质量工程师 上海

月薪： 0.7-1万/月

该公司所有职位
  • 3-4年经验
  • 大专
  • 招1人
  • 11-20 发布

职位描述

职位描述： Responsibilities (fundamental job duties) 职责:?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。?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。?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。?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。?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。?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。?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。?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。?Manage the engineering change of suppliers, and ensure all engineering change can only be implemented after it’s approved by Mira MEDsource 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明若和客户批准后才能被执行。?Participate in the establishment and maintenance of QMS of Mira MEDsource, including participating in the internal audit, drafting or updating documents of QMS, etc. 参与建立和维护明若的质量管理体系，包括参与内审，编写和更新质量体系文件。?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。?Participate in the continuous improvements activities of Mira MEDsource about the product quality and/or cost, supply chain optimization and business process improvement. 参与明若的产品质量或成本持续改进活动，供应链优化和业务流程改进。?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。Reporting Relationships: 汇报关系Position reports to汇报对象: Quality and Regulatory Compliance Manager质量保证和法规事务经理Positions reporting to this job负责对象: None无Minimum Requirements职位要求: ?College degree is required, major in Science or Engineering discipline is preferred. 大学毕业，科学或工程专业。?Minimum 4 years’ QA or RA 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4年以上的QA或RA工作经验。?Medical device regulatory knowledge including USA, EU and China. 掌握一定的中国，欧洲和美国的医疗器械法规知识。?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。?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。?Familiar with sampling inspection related standards (i.e. ANSI Z1.4, GB2828, etc.), and have the experience of product inspection/test. 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。?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。?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。?Fluent in English - both written and oral is a must. 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。 职能类别： 医疗器械生产/质量管理 生物工程/生物制药 关键字： 质量/医药

联系方式

上海市长宁区遵义路100号南丰城B幢1801&1816单元

公司信息

Mira MEDsource is a wholly owned foreign enterprise affiliated with Owens & Minor, and serves as the sourcing arm of Owens & Minor. Mira MEDsource is dedicated to providing high-quality products at the most competitive prices, while delivering consistent value and unmatched service. Through a shared commitment to the highest standards of professional ethics and integrity, Mira MEDsource looks to partner with suppliers and manufacturers to develop and maintain mutually beneficial, long-term relationships.Owens & Minor, a Fortune 500 company, is the leading distributor of name-brand medical/surgical supplies in the United States. Owens & Minor delivers thousands of vital products to approximately 4,400 healthcare provider customers domestically from 50 distribution centers. Owens & Minor also distributes its private label MediChoice brand products which offer quality, value-priced products backed by Owens & Minor's signature customer service. Owens & Minor is dedicated to the wellbeing of its teammates, and to delivering value for its customers, its supplier partners, and its shareholders since 1882. Owens & Minor...Delivering More.上海明若医疗器械贸易有限公司是美国500强企业Owens & Minor公司在国内的独资企业，也是Owens & Minor公司在本土以外的首个投资项目，主要从事一次性医疗器具的全球采购和供应链管理。Owens & Minor公司是美国医疗市场一次性医疗器具和外科手术用品的最大经销商以及医疗系统供应链管理方案的主要提供商。通过其50个配送中心，Owens & Minor公司为美国4500家医院、综合医疗系统、医护中心销售其自主品牌MediChoice产品，并提供众多的产品增值服务。自1882年成立以来，Owens & Minor公司就一直发扬有着130多年悠久历史的企业文化传统，专注于关心员工福祉，为客户、供应商、合作伙伴和股东创造最优价值。上海明若公司致力于提供品质稳定并具价格竞争力的产品，以及让客户满意的售后服务。本着遵守高标准的职业道德和诚信的共同承诺，明若公司将与客户和全球的供应商建立、发展互惠互利、长期合作的伙伴关系。公司正式员工福利：1.固定双休、法定节假日及各类带薪假；2.为正式员工缴纳五险一金，公司还额外购买补充医疗保险，个人意外险及独生子女福利；3.员工关怀：午餐补贴、生日活动、节假日福利、年度免费健康体检等；4.丰富的企业文化活动，定期的team bulding和team event；

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