Quality Engineer, Medical Devices

BACK TO JOBS Quality Engineer, Medical Devices APPLY NOW Quality Engineer, Medical Devices Company: High-Growth Interventional Medical Device Company Location: Minneapolis, MN Employment Type: Permanent The Opportunity Brio Resource Group is partnering with a growing medical device company to identify a proactive, hands-on Quality Engineer . This position will support both Quality Management System activities and product quality across development and commercial operations. The successful candidate will gain broad exposure to Quality Systems, Operations Quality, Supplier Quality, and Design Assurance while working closely with a highly supportive leadership team in a fast-moving startup environment. This is an excellent opportunity for a rising Quality professional who takes ownership, values variety, and wants their responsibilities to expand as the company grows. Key Responsibilities Manage document-control activities and coordinate document change requests from initiation through closure. Generate and maintain quality documentation supporting commercial operations and product-development programs. Perform product acceptance, release, receiving inspection, and nonconforming-material activities. Maintain product and material traceability within the Quality Management System. Administer complaint, feedback, nonconformance, and CAPA processes. Lead or support investigations, root-cause analysis, corrective actions, effectiveness checks, and quality trending. Partner with R&D on design controls, risk management, verification and validation, sample plans, and design transfer. Support manufacturing through lot-documentation review, training coordination, equipment controls, and production-environment oversight. Participate in process validation, equipment qualification, test-method validation, and manufacturing process changes. Support supplier qualification, performance monitoring, corrective actions, and supplier-related investigations. Evaluate product, process, equipment, material, and supplier changes for quality and validation implications. Analyze quality data across NCMRs, complaints, CAPAs, suppliers, and manufacturing to identify recurring issues and improvement opportunities. Support ISO 13485 audits, customer audits, regulatory inspections, audit responses, and follow-up activities. Collaborate closely with Engineering, Operations, Regulatory Affairs, Quality, and company leadership. Qualifications Bachelor’s degree in mechanical, biomedical, industrial, manufacturing, or another relevant engineering discipline. Approximately two to five years of Quality Engineering, Manufacturing Engineering, or related experience. Strong technical-writing, documentation, organizational, and time-management skills. Ability to interpret engineering drawings, specifications, inspection requirements, and technical procedures. Strong analytical and problem-solving skills, including root-cause analysis. Demonstrated ability to work independently, take ownership, and manage multiple priorities. Working knowledge of Microsoft Office and the ability to learn electronic QMS and ERP platforms. Practical understanding of engineering and manufacturing issues as they relate to product quality. Collaborative, detail-oriented approach with the initiative to succeed in a fast-paced environment. Preferred Experience Medical-device Quality Engineering or Manufacturing Engineering experience. Knowledge of ISO 13485, ISO 14971, FDA QMSR, 21 CFR requirements, and medical-device design controls. Experience with CAPAs, nonconforming products, complaints, supplier quality, and investigations. Experience supporting design transfer and medical-device commercialization. Experience with process validation, equipment qualification, test-method validation, or manufacturing process development. Participation in ISO, FDA, customer, or other quality-system audits. Experience using an electronic QMS or ERP system. Previous experience within a small or rapidly growing medical device company. Why Consider This Opportunity? This role offers broad exposure across operational, development, supplier, and systems quality within a growing medical device company. You will work closely with supportive leaders, contribute directly to daily business and product priorities, and expand your responsibilities as the organization grows. We will provide a complete job description, benefits information, and additional company details after an initial résumé review.