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.