Senior Staff Quality Engineer

What You Will Do

• 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.

What you need

Preferred

United States of America Pay Ranges

• USN : $102,600 - $171,000 USD Annual
• View the U.S. work location and transparency guide to find the pay range for your location.

Requirements

• Bachelor’s degree in engineering, Quality, Life Sciences, Regulatory Affairs, or a related technical discipline.
• 7+ years of experience in Quality Engineering, Quality Assurance, or Regulatory Affairs within a regulated industry; medical device experience preferred.
• Strong understanding of medical device manufacturing processes, ISO 13485, GMP, and quality system requirements.
• Demonstrated expertise in quality engineering principles including CAPA, Risk Management, Root Cause Analysis, Audits, Validation, and Statistical Methods.
• Experience with risk-based methodologies and statistical techniques, including Process Risk Assessments, Statistical Sampling Plans, Process Capability Analysis, and Gauge R&R studies.
• Strong analytical, problem-solving, critical thinking, and decision-making skills with exceptional attention to detail.
• Ability to communicate effectively across all levels of the organization and influence cross-functional stakeholders.
• Proven ability to lead quality initiatives, mentor others, and drive compliance with technical, regulatory, and quality requirements.
• Self-starter with the ability to manage multiple priorities in a fast-paced, collaborative manufacturing environment.
• Strong interpersonal, conflict resolution, and relationship-building skills with a customer-focused, stakeholder-oriented approach.