Quality Engineer: Process Control & CAPA Specialist

Stryker Corporation; Kalamazoo (MI); Hybrid; Confidential; Full time

Job summary

Stryker Corporation in Kalamazoo, MI is seeking a Quality Engineer to partner with operations, engineering, and quality teams to support process control, testing, and inspection activities that ensure products function as designed and meet established quality standards.

The role emphasizes method development, corrective actions, data analysis, supplier quality, and risk-based decision making to maintain compliance and drive continuous improvement across manufacturing.

Qualifications

• Bachelor’s degree in Engineering required.
• 0+ years of quality engineering experience in a regulated industry preferred.
• Experience with root cause analysis, CAPA, and process improvement preferred.
• Familiarity with metrology, GD&T, and inspection methods preferred.

Responsibilities

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention.
• Investigate nonconformances and support corrective actions in line with quality system requirements.
• Review and document nonconforming product through MRB, including containment and escalation.
• Analyze quality data and KPIs, identify trends, and address risks.
• Support evaluation of manufacturing and supplier changes for quality and risk impacts.
• Support supplier quality improvements, including corrective action management and part certification.
• Apply statistical methods and risk management to support process capability and sampling plans.
• Support internal/external audits, manufacturing transfers, engineering changes, and field investigations.
• Collaborate with manufacturing and engineering to resolve quality issues impacting production.

Skills

Quality engineering

Metrology

GD&T

Inspection methods

Education

Bachelor's degree in Engineering

Job description

Stryker Corporation in Kalamazoo, MI is seeking a Quality Engineer to partner with operations, engineering, and quality teams to support process control, testing, and inspection activities that ensure products function as designed and meet established quality standards.

The role emphasizes method development, corrective actions, data analysis, supplier quality, and risk-based decision making to maintain compliance and drive continuous improvement across manufacturing.