Senior Manager Quality Engineering - Medical Device

Responsibilities: Lead Quality activities associated with the evaluation, audit, qualification, selection, and onboarding of new contract manufacturers and critical suppliers. Own the Quality portion of manufacturing transfer projects, including process validation, production controls, inspection methodologies, acceptance criteria, traceability, DMR, DHR, and change management activities. Develop and manage supplier quality systems including supplier monitoring, supplier audits, quality agreements, SCARs, nonconformances, and CAPAs. Serve as the Quality lead during supplier and manufacturing qualification efforts. Own and continuously improve the company’s Quality Management System. Manage document control, change control, training programs, internal audits, management reviews, product release activities, and quality records. Oversee complaint handling, vigilance activities, MDR reporting, and post-market quality processes. Ensure FDA inspection readiness and support regulatory audits and inspections. Partner cross-functionally with Operations, Manufacturing, Supply Chain, and Regulatory teams to support business and quality objectives. Drive quality metrics, risk management activities, and continuous improvement initiatives. Maintain hands-on involvement in daily Quality operations rather than functioning solely as a people manager.

Qualifications: Strong medical device Quality experience within Class II medical devices required. Experience leading or supporting manufacturing transfers, supplier transitions, or contract manufacturer changes strongly preferred. Experience qualifying and managing contract manufacturers, sterilization providers, and critical suppliers. Working knowledge of FDA Quality System Regulations, Design Controls, and medical device Quality Management Systems. Experience with process validation, inspection methods, production controls, DMR, DHR, traceability, and change control. Experience managing supplier quality programs, CAPAs, nonconformances, and quality agreements. Experience supporting complaint handling, MDR reporting, audits, and FDA inspections. Regulatory experience, including 510(k) submissions and regulatory documentation, is a plus. Demonstrated ability to operate independently within a small-company environment. Strong project management, communication, and cross-functional leadership skills. Chicago-based candidates strongly preferred. Willingness to travel to contract manufacturers, suppliers, and external partners as needed.

Base Salary: Competitive