Hiring: Staff Quality Engineer Company: Stryker Location: Arlington, TN Job Posted Time: 2026-09-11 11:22:45 Target Skills & Keywords : Change Management, Quality Assurance, R, Regulatory Compliance, Risk Management, Root Cause Analysis, Six Sigma About the job Experience: •4+ years of experience in Quality Engineering, Quality Assurance, or Regulatory Affairs within a regulated industry; medical device experience preferred. Required Skills: •Provide quality leadership and oversight for manufacturing processes and product quality. •Own and drive investigations, nonconformances (NCs), corrective and preventive actions (CAPAs), and root cause analysis activities. •Partner closely with Operations, Engineering, Supply Chain, and cross-functional business teams to provide quality oversight and direction on product and process performance while ensuring compliance with ISO 13485, GMP, regulatory requirements, and Stryker Quality Systems. •Lead investigations and resolution of internal and supplier-driven nonconformances (NCs), driving timely containment, root cause analysis, corrective and preventive actions (CAPAs), and effective closure. •Disposition nonconforming products through Material Review Board (MRB) processes, issue nonconformances as appropriate, and support product holds, potential product escapes, and quality risk mitigation activities. •Serve as a subject matter expert in risk management, CAPA, change management, concession management, validation, statistical techniques, inspection methods, sampling plans, process capability, and quality system requirements. •Develop, assess, and approve quality-related changes, concessions, and risk management activities through data-driven decision making and sound quality engineering principles. •Analyze quality metrics and KPI trends, identify opportunities for improvement, and implement corrective actions that drive operational excellence and continuous improvement. Qualifications: •Medical device industry experience supporting manufacturing operations. •Lean Six Sigma certification or formal training. •Demonstrated success applying continuous improvement methodologies and Human Error Prevention principles within manufacturing environments. •Willingness to travel as needed and collaborate within a multi-site global organization. •Developing overlays, develop inspection methods, Gages, GD&T understanding, Print reading. •View the U.S. work location and transparency guide to find the pay range for your location. Compensation: •$89,300 - $148,800 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!