Support the implementation, maintenance, and continuous improvement of the iso 13485 quality management system. Develop, document, and revise quality procedures, create work instructions, and policies to align with iso standards. Establish and maintain detailed quality documentation, including control plans, process flow diagrams, pfmea, and inspection plans. Iso lead auditor certification. Ability to support inspection of first articles, in-process parts, and products prior to shipment using gauges, coordinate measuring machine, optical comparators, and vision. Ability to perform measurements and data collection in support of spc activities and product validations.3+ years of experience as a quality engineer in an injection moldingexperience in molding process, mold validation and direct participation in molded part transfer projects.support the implementation, maintenance, and continuous improvement of the iso 13485 quality management system.
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