Senior Staff Quality Engineer

What You Will Do

Work Flexibility: Onsite Stryker is seeking a Senior Staff Quality Engineer in Arlington, TN to provide quality leadership across manufacturing operations and cross-functional business teams. This role is responsible for driving quality excellence through risk management, CAPA ownership, supplier quality oversight, audit participation, and continuous improvement initiatives. The successful candidate will serve as a quality subject matter expert, ensuring compliance with FDA, ISO 13485, GMP, and Stryker Quality System requirements while influencing business performance through data-driven decision making. 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. Lead and support local and global quality initiatives, utilizing Lean, Six Sigma, Human Error Prevention, and risk-based methodologies to improve product quality and manufacturing performance. Optimize inspection methods, statistical sampling approaches, and process controls to ensure product quality, process capability, and compliance with established standards. Participate in and lead internal, external, customer, supplier, and regulatory audits, including audit preparation, logistics coordination, response development, and engagement with regulatory agencies. Support validation strategies, execution, and approval activities while ensuring compliance with applicable quality and regulatory requirements. Lead or support manufacturing transfers, process changes, and product launches across facilities, ensuring quality objectives and regulatory requirements are maintained. Manage supplier quality relationships through performance monitoring, quality issue resolution, nonconformance management, corrective actions, and continuous improvement initiatives. Coach, mentor, and provide technical leadership to quality professionals and cross-functional teams on quality systems, risk management, CAPA, problem-solving methodologies, and regulatory compliance. Represent Quality on local, global, and corporate review boards, providing expert input, technical guidance, and strategic recommendations that support business objectives and product quality.