Quality Engineer

Scanlan International, Inc., is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Quality Engineer to join our organization and continue this commitment. The Quality Engineer is responsible for supporting product quality, supplier quality, and continuous improvement activities across manufacturing and supply chain operations. This role partners with Engineering, Instrumentation, Purchasing, Regulatory, external artisans and suppliers to ensure materials, processes, and finished products meet company requirements, customer expectations, and applicable quality system standards. The position will lead customer complaint investigations, supplier qualification and monitoring, nonconformance investigations, corrective and preventive actions, process improvement, and quality planning activities. The ideal candidate combines strong technical judgment, data-driven decision making, supplier-facing communication skills, and hands-on experience in a regulated manufacturing environment. This position is located at our headquarters office, south of downtown St. Paul. We welcome an on-site work environment from Monday to Friday. This position reports to the Quality Manager What You’ll Do As a Quality Engineer: 35% - Quality Engineering support: Support and maintain quality engineering activities for assigned products, processes, suppliers, and purchased components. Lead investigations for nonconforming material, production quality issues, supplier quality concerns, and customer-related quality events. Initiate, review, approve, and verify the effectiveness of supplier corrective action requests and internal CAPA activities as assigned. Drive root cause analysis and corrective/preventive action using structured problem-solving methods such as 5 Why, fishbone analysis, 8D, or similar tools. 35% - Supplier Quality support: Evaluate supplier performance through scorecards, trend analysis, quality metrics, on-time response, audit results, and defect performance. Participate in supplier selection, qualification, approval, development, monitoring, and periodic re-evaluation activities. Plan, conduct, or support supplier audits and follow up on audit findings through closure. Review supplier manufacturing processes, inspection methods, control plans, process capability, and change notifications for quality impact. 20% - Quality Control support: Support the continuous improvement of incoming inspection requirements, sampling plans, inspection criteria, and measurement methods. Chair MRB meetings to determine disposition of nonconforming materials. 10% - Quality Management System support: Collaborate with Engineering and Instrumentation on design changes, process changes, validation activities, risk assessments, and transfer-to-production work. Analyze quality data to identify trends, recurring issues, supplier risks, and opportunities for improvement. Support development and maintenance of quality documentation, procedures, work instructions, specifications, forms, and records. Promote compliance with applicable quality system requirements, customer requirements, regulatory expectations, and internal procedures. Communicate quality expectations clearly to internal and external stakeholders, including timely escalation of significant risks or performance issues. Required Qualifications: Education: Bachelor’s degree in Engineering, Quality, Manufacturing, Industrial Technology, Life Sciences, or a related technical discipline; equivalent experience may be considered. Experience: Three or more years of experience in quality engineering, supplier quality, or a related technical quality role. Skills Working knowledge of quality system requirements and regulated manufacturing practices, such as ISO 9001, ISO 13485, FDA Quality Management System…

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