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Manufacturing Assembler II

Fremont, California 94538 | Contract to Direct

Post Date: 08/22/2017 Job ID: 72485 Category: Electrical-Electronics-Electromechanical Assembler

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SUMMARY This position is responsible for manufacturing, assembly and packaging. The position is also responsible for complying with applicable quality medical device manufacturing standards, such as ISO, QSR? s, and AAMI/ANSI. Candidate must have some technical and Electro/mechanical skills. ESSENTIAL DUTIES AND RESPONSIBILITIES -The position is responsible for all aspects of Manufacturing, Assembly & Packaging, Product Quality -Perform production line activities, including manufacturing of test strips, packaging of test strips, product labeling for shipment to meet production schedules and quality requirements -Assist with inspection of incoming parts/components, intermediate, and final product -Assist with preparation of line clearance for Test Strip and Meter Manufacturing -Assist in scheduling of daily tasks and/or activities for Test Strip and Meter manufacturing -Assist in dispensing of parts, components or material -Interact with team members to meet/exceed production needs/schedule, as defined by management -Assist in other manufacturing areas and activities QUALIFICATIONS -Understanding of FDA Quality System Regulations (21 CFR Part 820), ISO 13485 Medical devices? Quality Management Systems, Canadian Medical Device Regulations (CMDR? SOR/98-282), In Vitro Diagnostic Directive (98/79/EC) and all relevant standards as outlined in the company? s Quality Manual is preferred -Require strong oral, written, interpersonal, and skills in English -Must be able to operate the following equipment: a personal computer, printer and copier -Experience using Microsoft Word and Excel -Must be able to multitask -Ability to perform detail oriented work with a high degree of accuracy and recall. Individual must be able to perform each essential duty satisfactorily EDUCATION and/or EXPERIENCE -High School Diploma or equivalent -At least one(1) year experience in a medical device/pharmaceutical

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