上海招聘

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.
? Participate in supplier qualification and interface directly with manufacturing, sourcing to ensure product quality.
? Conduct supplier audit and drive supplier to complete all the corrective actions and preventive actions (CAPA) effectively.
? Communicate quality standards of products to suppliers; review the product specification of suppliers to make sure it complies with the industry standards, regulations and the requirement of customers.
? Review, evaluate and conduct first article inspection (FAI) to qualify the products of suppliers.
? Establish the product inspection procedure, train the quality inspectors, review the inspection report of quality inspectors and perform the product inspection at supplier sites by oneself if necessary.
? Work with suppliers to investigate and handle the customer complaints, including driving suppliers to take necessary CAPAs to improve the quality and/or service, and answer the questions received from organizations within the supply chain and customers.
? Participate in the continuous improvements activities of Mira MEDsource about the product quality and/or cost, supply chain optimization and business processes.
? Perform routine quality monitor program for critical suppliers.
? Participate in the supplier performance appraisal and regular supplier performance review.
? Manage the engineering change of suppliers, and ensure all engineering change can only be implemented after the engineering change application of suppliers is approved by Mira MEDsource and related customers.
? Participate in the establishment and maintenance of QMS of Mira MEDsource, including participating in the internal audit, drafting and/or updating SOPs.

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Reporting Relationships:
Position reports to: Quality and Regulatory Compliance Manager
Positions reporting to this job: None


Minimum Requirements:
? College degree is required, major in Science or Engineering discipline is preferred.
? Minimum 4 years’ QA or RA working experience in the medical device or pharmaceutical industries.
? Medical device regulatory knowledge including USA, EU and China, sterilization knowledge (i.e. EO, Gamma, Steam) and process validation knowledge.
? Familiar with the standards or regulations of QMS related (i.e. ISO9000 / ISO13485, US FDA QSR820, etc.), and have the solid experience of leading a QMS audit for suppliers.
? Familiar with sampling inspection related standards (i.e. GB2828, etc.), and have the solid experience of product inspection/test.
? Experience of medical device product registration is preferred.
? 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.

Mira MEDsource is a joint venture entity of Owens & Minor and Amsino Medical Group, 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 and Minor公司与美诺医疗集团合资的企业，是Owens & Minor公司在美国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，公司还额外购买个人商业医疗保险；
3.员工关怀：午餐补贴、生日、季度电影、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；