Senior Quality Engineer

We anticipate the application window for this opening will close on - 7 Nov 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life                     Cranial & Spinal Technologies (CST) develops therapies, technologies, and procedural solutions for the treatment of disorders and injuries affecting the spine and cranial anatomy. The operating unit partners with healthcare providers worldwide to advance surgical outcomes through innovative implants, navigation, imaging, enabling technologies, and procedural excellence.   Check us out on LinkedIn: Medtronic CST   This position is based in Boxborough, Massachusetts, and supports onsite collaboration with cross-functional teams across Quality, Manufacturing, Operations, Research and Development, and Regulatory Affairs. This is an onsite role with no travel required.   The Senior Quality Engineer serves as a quality representative supporting manufacturing operations, process improvements, product quality initiatives, and regulatory compliance activities. This role partners across functions to drive product quality, ensure process effectiveness, investigate quality issues, and support continuous improvement efforts throughout the product lifecycle.   Primary Responsibilities • Lead quality engineering activities supporting manufacturing processes and product quality performance. • Partner with Manufacturing, Operations, and Research and Development teams to implement process improvements and quality controls. • Analyze quality data, identify trends, and drive corrective and preventive actions to address nonconformances. • Support root cause investigations and resolution of product, process, and supplier quality issues. • Develop, review, and approve quality documentation, procedures, validation protocols, and engineering changes. • Ensure compliance with applicable Quality Management System requirements and regulatory standards. • Participate in risk management activities and support product and process risk assessments. • Drive continuous improvement initiatives that enhance product quality, process capability, and operational performance.   Required Qualifications • Bachelor's degree and 4+ years of quality engineering, manufacturing, or regulated industry experience OR an advanced degree and 2+ years of quality engineering, manufacturing, or regulated industry experience. • Experience applying quality tools for root cause analysis, corrective actions, and process improvement. • Experience supporting quality systems within a regulated environment. • Experience analyzing quality data and developing effective quality solutions. • Working knowledge of process validation, risk management, or quality engineering methodologies.   Preferred Qualifications • Experience in medical device manufacturing. • Knowledge of United States Food and Drug Administration regulations, ISO 13485, and Quality System requirements. • Experience with nonconformance, corrective and preventive action, and change control processes. • Experience supporting product transfers, process validations, or manufacturing process improvements. • Certification as a Quality Engineer or related quality certification through the American Society for Quality.   For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 21