Anna Zeimet
Quality Engineer @Osypka Medtec Inc
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WORK HISTORY
Quality Engineer @Osypka Medtec Inc
Controls, runs, and organizes the quality management system for an ISO 13845 / 21CFR Part 11 regulated manufacturing environment producing Class II and Class medical devices Investigates, analyzes, and corrects quality problems related to products, including incoming material inspections, quality inspections of work in process, and final product Analyze and provide input regarding quality of raw materials, purchased parts, and other materials required in manufacturing Inspect consumables, raw materials, components, tools, and other parts as required Maintain and update quality assurance documents including procedures, the quality manual, PFMEA, change orders, and other documents Initiate investigations and take necessary actions such as NCRs and CAPAs based on careful root cause analysis and analysis of trends Plan and execute phases of quality assurance activities of new and existing projects such that product quality, schedules, and timelines are ensured to meet both engineering and customer’s needs Coordinate requests for change orders, including preparing supporting documentation, communications, sample part review, and scheduling of projects for engineering and quality
EDUCATION
University of Minnesota
Master of Education - MEd, Elementary Education and Teaching
University of Minnesota
Bachelor of Science - BS, Education
ABOUT ANNA ZEIMET
At Osypka Medtec Inc, my role as Quality Engineer revolves around the meticulous…
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