Senior Design Quality Engineer

3 weeks ago


Chicago, United States Barrington James Full time

Senior Design Quality Engineer - (Medical Device) - Hybrid in Chicago, IL Our client is at the forefront of medical device innovation, committed to enhancing patient outcomes with cutting-edge technology and innovative design. They have dedication to quality and are looking for a Senior Design Quality Engineer to join their growing team. As Senior Design Quality Engineer you will be working 2 days a week onsite in Chicago. In this role, you will ensure the quality and compliance of medical device designs throughout the product development lifecycle. This position requires a deep understanding of design controls, risk management, and regulatory requirements. Key Responsibilities: Lead design quality activities for new product development and sustaining engineering projects. Develop and implement design control procedures in line with FDA, ISO 13485, and other regulatory requirements. Conduct design reviews, risk assessments, and failure mode effects analysis (FMEA) to ensure product safety and efficacy. Collaborate with R&D, manufacturing, regulatory, and marketing teams to meet design quality objectives. Review and approve design verification and validation plans, protocols, and reports. Support regulatory submissions with necessary design quality documentation and evidence. Monitor and analyze design-related quality metrics, driving continuous improvement initiatives. Manage all parts of the Quality System - CAPA, Design Controls, Document Controls, Complaints, pFMEA, dFMEA, and uFMEA. Stay current with industry trends, standards, and regulations to ensure compliance and innovation. Qualifications: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical) or relevant field; advanced degree preferred. 7-10 years of experience in design quality engineering within the medical device industry. Strong knowledge of FDA regulations, ISO 13485, ISO 14971, IEC 60601, and 21 CFR Part 820. Proven experience with design controls, risk management, and product development processes. Excellent analytical and problem-solving skills, with keen attention to detail. Strong communication and interpersonal skills, with the ability to work effectively in a team. Certification in quality engineering (e.g., CQE, Six Sigma) is a plus. Proficiency in quality management software and tools. If you would like to learn more about this Senior Design Quality Engineer then apply today or reach out to me: wjlynch@barringtonjames.com



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