Senior Quality Engineer

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

At Stryker, our quality engineers play a critical role in ensuring products consistently meet defined quality and regulatory requirements.

We are hiring a Senior Quality Engineer in Kalamazoo, MI supporting Instruments! In this role, you will develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products function as designed and meet established quality standards. You will work closely with operations, engineering, and suppliers, with direct impact across product quality, supplier performance, and manufacturing process control throughout the product lifecycle.

What You Will Do

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operations
• Investigate internal and supplier-related nonconformances, lead root cause analysis, and manage timely corrective and preventive actions in alignment with quality system requirements
• Review, disposition, and document nonconforming product through formal material review processes, including containment and escalation when required
• Analyze quality data and key performance indicators, identify trends, and initiate actions to address emerging product or process risks
• Evaluate manufacturing and supplier changes, including process updates and component changes, to assess quality and risk impacts prior to implementation
• Support supplier quality improvement activities, including corrective action management, part certification initiatives, and ongoing performance monitoring
• Apply statistical methods and risk management practices to support process capability, inspection strategies, and sampling plans
• Support internal and external audits, manufacturing transfers, engineering changes, and field-related quality investigations as a subject matter resource
• Collaborate closely with manufacturing and engineering teams to identify, investigate, and resolve quality issues impacting production

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field
• Minimum 2 years of quality engineering or related quality experience within a regulated industry

Preferred Qualifications

• Experience working with U.S. and international medical device regulatory requirements
• Experience managing nonconformance investigations and corrective action activities in a regulated quality system
• Experience supporting supplier quality activities or manufacturing process improvements
• Experience applying risk management and statistical process control methods in manufacturing environments

United States of America Pay Ranges:

USN: $77,700 - $129,500 USD Annual

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