Senior Quality Engineer: Medical Devices & Process Excellence

Stryker; Kalamazoo (MI); On-site; USD 78,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan

Wellbeing program

Job summary

Stryker in Kalamazoo, MI is seeking a Senior Quality Engineer to develop and implement quality methods across manufacturing. You will lead root cause analyses, manage corrective actions, and collaborate with operations, engineering, and suppliers to ensure product quality and regulatory compliance.

The role emphasizes process control, data analysis, and risk assessment to support product lifecycle quality improvements and supplier performance enhancements.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum 2 years of quality engineering experience within a regulated industry.
• Experience with medical device regulatory requirements is preferred.

Responsibilities

• 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 corrective and preventive actions.
• Review and disposition nonconforming product through material review processes, including containment and escalation.
• Analyze quality data and KPIs, identify trends, and initiate actions to address risks.
• Evaluate manufacturing and supplier changes for quality and risk impact prior to implementation.
• Support supplier quality improvement activities and ongoing performance monitoring.
• Apply statistical methods and risk management to support process capability and sampling plans.
• Assist audits, transfers, engineering changes, and field quality investigations as a SME.
• Collaborate with manufacturing and engineering to resolve production quality issues.

Skills

Quality engineering experience

Regulated industry exposure

Education

Bachelor’s degree in Engineering, Science, or a related technical field

Job description

Stryker in Kalamazoo, MI is seeking a Senior Quality Engineer to develop and implement quality methods across manufacturing. You will lead root cause analyses, manage corrective actions, and collaborate with operations, engineering, and suppliers to ensure product quality and regulatory compliance.

The role emphasizes process control, data analysis, and risk assessment to support product lifecycle quality improvements and supplier performance enhancements.