Senior Quality Engineer - Medical Devices & Process Risk

Stryker Group; Kalamazoo (MI); Hybrid; USD 78,000 - 130,000; Full time

Job summary

Stryker is hiring a Senior Quality Engineer in Kalamazoo, MI to develop and implement quality methods for process control, inspection, testing, and defect prevention across manufacturing operations.

You will lead root cause analyses, manage CAPAs, review nonconforming products, and analyze quality data to identify risks. Collaboration with suppliers, operations, and engineering is essential to ensure device quality throughout the lifecycle.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field.
• At least 2 years in quality engineering within a regulated industry.
• Experience with nonconformance investigations and CAPAs is preferred.
• Experience supporting supplier quality or process improvements is a plus.
• Knowledge of risk management and SPC methods is preferred.

Responsibilities

• Develop and maintain quality methods for process control, inspection, testing, and defect prevention.
• Lead root cause analysis and corrective actions for nonconformances.
• Review and disposition nonconforming product through MRB, including containment.
• Analyze quality data to identify trends and mitigate risks.
• Evaluate changes to processes and components for quality impact.
• Support supplier quality improvement and ongoing performance monitoring.
• Apply statistical methods and risk management to process capability and sampling.
• Support audits, manufacturing transfers, and field quality investigations; collaborate with manufacturing and engineering to resolve quality issues.

Skills

Quality engineering

Root cause analysis

Process improvement

Regulatory compliance

Statistical methods

Education

Bachelor's degree in Engineering/Science or related field

Tools

Quality management systems

Job description

Stryker is hiring a Senior Quality Engineer in Kalamazoo, MI to develop and implement quality methods for process control, inspection, testing, and defect prevention across manufacturing operations.

You will lead root cause analyses, manage CAPAs, review nonconforming products, and analyze quality data to identify risks. Collaboration with suppliers, operations, and engineering is essential to ensure device quality throughout the lifecycle.