Staff Quality Engineer - Remote/Hybrid Manufacturing

Stryker Corporation; Kalamazoo (MI); On-site; Confidential; Full time

Job summary

Stryker Corporation in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches, manufacturing transfers, and supplier quality initiatives. You will drive CAPA, PPAP, process validation, and risk management activities across life cycles and ensure regulatory compliance.

The role emphasizes cross-functional teamwork with operations, engineering, and suppliers, plus responsibilities for nonconformance investigations and trend analysis using

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical field.
• 4+ years in quality engineering, manufacturing quality, supplier quality, or related role.
• Experience leading or supporting cross-functional quality projects in a regulated environment.

Responsibilities

• Support quality deliverables for new product launches, manufacturing transfers, supplier changes, and engineering change initiatives.
• Partner with operations, engineering, supplier, and quality teams to ensure product and process quality performance.
• Own nonconformance investigations and drive containment, root cause analysis, correct actions, and record closure.
• Lead CAPA activities, including investigation, implementation, and effectiveness verification.
• Review and disposition nonconforming materials; support material review and quality decisions.
• Execute PPAP activities and support manufacturing readiness for changes.
• Support process validation, equipment qualification, MSA, and risk management.
• Monitor quality metrics, analyze trends using statistical methods and process control tools.

Skills

Quality Engineering

Project Leadership

Regulatory Compliance

CAPA Management

Education

Bachelor's degree in Engineering

Tools

SPC

MSA

CMMs

GD&T

Job description

Stryker Corporation in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches, manufacturing transfers, and supplier quality initiatives. You will drive CAPA, PPAP, process validation, and risk management activities across life cycles and ensure regulatory compliance.

The role emphasizes cross-functional teamwork with operations, engineering, and suppliers, plus responsibilities for nonconformance investigations and trend analysis using