Staff Quality Engineer — MedTech Quality & Process

Stryker Group

Kalamazoo (MI)

On-site

USD 89,000 - 149,000

Full time

4 days ago
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Job summary

Stryker Group in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches, manufacturing transfers, and supplier changes within Surgical Technologies. You will engage with cross-functional teams to assure product and process quality across the full lifecycle, including post-handoff sustainment and regulatory compliance.

You will lead nonconformance investigations, CAPA, PPAP, MSA, and risk management activities, monitor quality metrics,

Qualifications

  • Bachelor’s degree in Engineering, Science, or related technical field.
  • Minimum 4 years of quality engineering or related experience.
  • Experience in regulated environments with product launches or manufacturing transfers.

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, corrective actions, and record closure.
  • Lead CAPA activities, including investigation, implementation, and effectiveness verification.
  • Review and disposition nonconforming materials and support 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 drive continuous improvement.

Skills

Quality engineering
Cross-functional collaboration
CAPA
PPAP
MSA
SPC
GD&T
Six Sigma
CMM metrology

Education

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

Tools

Calipers
Micrometers
Pin gauges
CMMs

Job description

Stryker Group in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches, manufacturing transfers, and supplier changes within Surgical Technologies. You will engage with cross-functional teams to assure product and process quality across the full lifecycle, including post-handoff sustainment and regulatory compliance.

You will lead nonconformance investigations, CAPA, PPAP, MSA, and risk management activities, monitor quality metrics,

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