-
8-9年经验 -
招1人 -
英语熟练 -
11-20 发布
- 五险一金
- 员工旅游
- 交通补贴
- 餐饮补贴
- 通讯补贴
- 专业培训
- 出国机会
- 年终奖金
- 弹性工作
- 定期体检
职位描述
职位描述： Responsibilities (fundamental job duties):?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.?Work with sourcing to select, evaluate potential suppliers, and qualify new suppliers for sourcing projects. And write or compile related report in English.?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.?Conduct supplier audit to assess the compliance and effectiveness of QMS of suppliers, and drive suppliers to improve the compliance and effectiveness of QMS.?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.?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.?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.?Work with sourcing and logistics to evaluate the performance of suppliers and push supplier to improve the performance.?Manage the engineering change of suppliers, and ensure all engineering change can only be implemented after it’s approved by Mira MEDsource and customers.?Participate in the establishment and maintenance of QMS of Mira MEDsource, including participating in the internal audit, drafting or updating documents of QMS, etc.?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.?Participate in the continuous improvements activities of Mira MEDsource about the product quality and/or cost, supply chain optimization and business process improvement.?Participate in establishing and/or maintaining the database of products, regulatory or suppliers.?Manage the team of quality inspectors; coordinate the activities of all product inspection, including pre-shipment inspection and product sterility testing.?Collect the data of KPI and provide KPI report to manager monthly.?Select, evaluate and qualify 3rd party contract sterilizer, and conduct annual surveillance audit for 3rd party contract sterilizer.Reporting Relationships:Position reports to: Quality and Regulatory Compliance ManagerPositions reporting to this job: Quality InspectorsMinimum Requirements:?College degree is required, major in Science or Engineering discipline is preferred;?Minimum 8 years’ QA or RA working experience in the medical device or pharmaceutical industries.?Medical device regulatory knowledge including USA, EU and China.?Wealthy sterilization knowledge (i.e. EO, Gamma, Steam) and process validation knowledge.?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.?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.?Quality tools knowledge and using skill, including SPC, FMEA, MSA, DOE, etc.?Experience of medical device product registration is preferred.?Strong leadership skill while possessing an outstanding team spirit.?Strong Negotiation and Problem solving skill.?Good presentation skills and the ability to provide training on topics related to duties and responsibilities as outlined.?Self-motivator, Result driving, Team-player & Can-Do attitude.?Fluent in English - both written and oral required.?Proficient with Microsoft Word, PowerPoint, Project and Excel required. 职能类别： 医疗器械生产/质量管理 关键字： Quality
联系方式
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；
