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QA Specialist 质量专员 (MJ000087)

9千-1.2万·13薪
上海市本科不限经验

职位描述

RESPONSIBILITIES
(1) Collect and review Device Master Record (DMR) documents for Medline products subject to the regulatory requirements and make trainings for Medline Asian suppliers on DMR requirements when necessary;
(2) Cooperate with supplier, engineering and Divisional QA (DQA) to create and maintain the Product Inspection Criteria in the order of priority, make sure no delay to inspection and shipment;
(3) Conduct sample construction review for new products, and assist in helping suppliers understand the product specifications;
(4) Complete monthly Complaint Trending Report, and make adjustment as requirement of DQA if some improvement needed;
(5) Complete Supplier Re-Evaluation by reviewing suppliers who have already been processed through the Vendor Evaluation Procedure and their approximate three-year review is approaching and providing corresponding dispositions;
(6) Collect all required product information, verify and record in Reliance in appropriate related documents to complete New Item Setup spreadsheet compilation;
(7) Review the Component Sourcing Form completed by suppliers, and assign Quality Warnings (QW Codes) based on the suppliers’ review results;
(8) Other projects assigned by managers/DQAs, such as deviation release and update, country code artwork release and follow up.
Qualification
(1) Education level: Bachelor degree;
(2) Working experience: 3-5 years working experience, at least 3 years’ experience on quality control or supplier quality management;
(3) Specific knowledge: Quality system knowledge of ISO13485 or IS09001 is a plus;
(4) Certifications: CET-6;
(5) Language: excellent verbal and written English.

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