Senior Staff Quality Engineer — Quality Leadership & CAPA

Stryker Group; Arlington (TN); Híbrido; USD 103.000 - 171.000; Jornada completa

Descripción de la vacante

Stryker Group seeks a Senior Staff Quality Engineer in Arlington, TN to provide quality leadership across manufacturing operations and cross-functional teams. You will drive CAPAs, risk management, supplier quality oversight, audits, and continuous improvement while ensuring compliance with FDA, ISO 13485, GMP, and Stryker Quality System requirements.

Lead investigations, MRB disposition, and quality changes using data-driven decisions.

Formación

• 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.

Responsabilidades

• Provide quality leadership and oversight for manufacturing processes and product quality.
• Own and drive investigations, nonconformances (NCs), CAPAs, and root cause analysis activities.
• Partner with Operations, Engineering, Supply Chain, and cross-functional teams to ensure quality oversight and regulatory compliance.
• Lead investigations and resolution of internal and supplier-driven NCs, driving containment, root cause analysis, CAPAs, and closure.
• Disposition nonconforming products through MRB processes, issue NCs, and support holds and potential product escapes.
• Serve as a subject matter expert in risk management, CAPA, change management, validation, statistics, inspection methods, sampling plans, process capability, and quality systems.
• Develop, assess, and approve quality-related changes, concessions, and risk management activities via data-driven decision making.
• Analyze quality metrics and KPI trends, identify opportunities for improvement, and implement corrective actions for operational excellence.
• Lead and support local and global quality initiatives using Lean, Six Sigma, and risk-based methodologies to improve quality and performance.
• Optimize inspection methods, sampling, and process controls to ensure product quality and compliance.
• Participate in and lead internal, external, customer, supplier, and regulatory audits; manage audit prep and responses.
• Support validation strategies, execution, and approval activities; ensure compliance with quality and regulatory requirements.
• Lead or support manufacturing transfers, process changes, and product launches across facilities with regulatory compliance.
• Manage supplier quality relationships through performance monitoring, issue resolution, corrective actions, and continuous improvement.
• Coach and mentor quality professionals and cross-functional teams on quality systems, risk, CAPA, and regulatory compliance.
• Represent Quality on review boards, providing expert input, guidance, and strategic recommendations.

Conocimientos

Quality leadership

CAPA

Risk Management

Root Cause Analysis

Audits

Process Improvement

Regulatory Compliance

Data-driven decision making

Educación

Bachelor's degree in engineering

Descripción del empleo

Stryker Group seeks a Senior Staff Quality Engineer in Arlington, TN to provide quality leadership across manufacturing operations and cross-functional teams. You will drive CAPAs, risk management, supplier quality oversight, audits, and continuous improvement while ensuring compliance with FDA, ISO 13485, GMP, and Stryker Quality System requirements.

Lead investigations, MRB disposition, and quality changes using data-driven decisions.