Senior Quality Engineer, MedTech (NPI, CAPA & PPAP)

Stryker; Kalamazoo (MI); On-site; USD 89,000 - 149,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

ESPP

Job summary

Stryker in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches and manufacturing transfers within Surgical Technologies. You will lead quality improvements, CAPA, PPAP, and risk management, partnering with cross-functional teams to assure compliance with regulatory standards and robust product quality throughout the lifecycle.

You will also support supplier quality issues, perform nonconformance investigations, and drive containment

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field is required.
• Minimum 4 years of experience in quality engineering, manufacturing quality, supplier quality, or related quality-focused engineering 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, corrective actions, and record closure.
• Lead CAPA activities, including investigation, implementation, and verification of effectiveness.
• Review and disposition nonconforming materials and support material review decisions.
• Execute PPAP activities and support manufacturing readiness for changes.
• Support process validation, equipment qualification, MSA, and risk management activities.
• Monitor quality metrics and use statistical tools to drive continuous improvement.

Skills

Quality engineering

Education

Bachelor's degree in Engineering, Science, or a related technical field

Tools

SPC

MSA

PPAP

CAPA

GD&T

CMMs

Job description

Stryker in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches and manufacturing transfers within Surgical Technologies. You will lead quality improvements, CAPA, PPAP, and risk management, partnering with cross-functional teams to assure compliance with regulatory standards and robust product quality throughout the lifecycle.

You will also support supplier quality issues, perform nonconformance investigations, and drive containment