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Staff Quality Engineer

Stryker
Kalamazoo, USA
Full-time
Senior · 4+ years experience
Onsite
USD 89300-148800 / year
Discovered 3 weeks ago

Full Job Posting

What You Will Do

  • 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 Corrective and Preventive Action (CAPA) activities, including investigation, implementation, and effectiveness verification.
  • Review and disposition nonconforming materials while supporting material review and quality decision-making processes.
  • Execute Production Part Approval Process (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.
  • What You Will Need

Required Qualifications

  • Bachelor’s degree in Engineering, Science, or a related technical field
  • Minimum 4 years of experience in quality engineering, manufacturing quality, supplier quality, or a related quality-focused engineering role
  • Experience leading or supporting cross-functional quality projects, including new product launches, manufacturing transfers, process improvements, or engineering change initiatives in a regulated environment.

Preferred Qualifications

  • 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 statistical process control (SPC), data analysis, and quality improvement methodologies.
  • Familiarity with geometric dimensioning and tolerancing (GD&T).
  • Experience using metrology equipment such as calipers, micrometers, pin gauges, and coordinate measuring machines (CMMs).
  • Familiarity with ISO 13485 and Good Manufacturing Practice (GMP) requirements.
  • Six Sigma Green Belt or Black Belt certification.
  • United States of America Pay Ranges:
  • USN: $89,300 - $148,800 USD Annual
  • View the U.S. work location and transparency guide to find the pay range for your location.

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