Staff Quality Engineer: Surgical Tech & Process Excellence

Stryker Corporation; Kalamazoo (MI); Hybrid; USD 89,000 - 149,000; Full time

Job summary

Stryker Corporation in Kalamazoo, Michigan is seeking a Staff Quality Engineer to deliver quality support across new product launches, manufacturing transfers, and supplier changes. You will drive CAPA, PPAP, and risk management to ensure product quality and compliance in a regulated environment.

Join a cross-functional team focused on continuous improvement, statistical methods, and robust process validation, with a strong emphasis on supplier quality and manufacturing readiness for changes.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Experience leading or supporting cross-functional quality projects, including new product launches, manufacturing transfers, process improvements, or engineering change initiatives in a regulated environment.
• Experience with quality systems, including nonconformance management, CAPA, audits, and risk management.
• Experience supporting process validation, equipment qualification, PPAP, and measurement system analysis (MSA).
• Familiarity with ISO 13485 and GMP requirements.
• Six Sigma Green Belt or Black Belt certification.

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 timely containment, root cause analysis, corrective actions, and record closure.
• Lead and support CAPA activities, including investigation, implementation, and effectiveness verification.
• Review and disposition nonconforming materials while supporting material review and quality decision-making processes.
• Execute PPAP activities and support manufacturing readiness for product and process changes.
• Support process validation, equipment qualification, measurement system analysis (MSA), and risk management activities.
• Monitor quality metrics, analyze trends using statistical methods and process control tools, and drive continuous improvement initiatives.

Skills

Quality leadership

CAPA investigations

PPAP

MSA

SPC

Data analysis

Risk management

GD&T

CMMs

Education

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

Tools

CMM

Calipers

Micrometers

Pin gauges

Job description

Stryker Corporation in Kalamazoo, Michigan is seeking a Staff Quality Engineer to deliver quality support across new product launches, manufacturing transfers, and supplier changes. You will drive CAPA, PPAP, and risk management to ensure product quality and compliance in a regulated environment.

Join a cross-functional team focused on continuous improvement, statistical methods, and robust process validation, with a strong emphasis on supplier quality and manufacturing readiness for changes.