Senior Staff Quality Engineer

Stryker Group; Arlington (TN); Hybrid; USD 103,000 - 171,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality leadership

CAPA

Risk Management

Root Cause Analysis

Audits

Process Improvement

Regulatory Compliance

Data-driven decision making

Education

Bachelor's degree in engineering

Job description

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.

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

• 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.

Preferred

• Medical device industry experience supporting manufacturing operations.
• Lean Six Sigma certification or formal training.
• Experience interacting with regulatory authorities such as FDA, TÜV, Notified Bodies, Ministry of Health (MoH), or other regulatory agencies.
• Experience supporting supplier quality, process validation, inspection optimization, and manufacturing transfers.
• Demonstrated success applying continuous improvement methodologies and Human Error Prevention principles within manufacturing environments.
• Experience leading cross-functional quality projects and representing Quality during audits, inspections, and business reviews.
• Willingness to travel as needed and collaborate within a multi-site global organization.
• Developing overlays, develop inspection methods, Gages, GD&T understanding, Print reading.Insert detailed job description here.

United States of America Pay Ranges:

• USN: $102,600 - $171,000 USD Annual

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