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UltiMed Inc

Full Time

Contact: Julia Tate
Phone: 6512917909

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This highly visible position is a key member of our skilled Quality Team at our De Smet, SD production plant. This role provides leadership for, 1 supplier quality management, 2 product quality management and 3 general quality assurance functions. The Quality Engineer acts as the point of contact for all quality issues relating to on-site manufacturing as well as supplied components from outside vendors as well as leading all quality and improvement activities and assuring that all quality requirements are in compliance with FDA, ISO, Canadian Medical Device Regulations and other standards. The Quality Engineer provides quality assurance technical support to operations in order to ensure product quality compliance and safety, and partners with our manufacturing counterparts to drive improvements relating to quality and quality systems. We offer a generous benefits package including medical, dental, vision, life and 401k with match. Competitive pay bonus potential -Assess and approve potential suppliers -Perform Quality audits to ISO, FDA and Canadian Medical Device Regulations -Manage the NCR, SCAR and CAPA processes -Analyze design specifications for both component and finished products -Perform investigations and analyze failure data See posting for full details on this pivotal role

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