Quality Engineer - Manufacturing Process Control & CAPA

Stryker Corporation; United States; On-site; Confidential; Full time

Job summary

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

The role focuses on investigating nonconformances, supporting CAPA, analyzing quality data, and ensuring supplier quality and change controls are effectively implemented in a fast-paced manufacturing environment.

Qualifications

• Bachelor’s degree in Engineering required.
• 0 years of quality engineering or related experience in a regulated industry 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, support root cause analysis, and assist with 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 KPIs, identify trends, and support actions to address product or process risks.
• Support the evaluation of 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.
• Collaborate closely with manufacturing and engineering teams to identify, investigate, and resolve quality issues impacting production.

Skills

Quality engineering

Root cause analysis

CAPA

GD&T knowledge

Education

Bachelor's degree in Engineering

Job description

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

The role focuses on investigating nonconformances, supporting CAPA, analyzing quality data, and ensuring supplier quality and change controls are effectively implemented in a fast-paced manufacturing environment.