Staff Quality Engineer
Core
Provide quality engineering support for new product launches, manufacturing transfers, and manufacturing sustainment in Surgical Technologies.
Role type
Staff Quality Engineer (Manufacturing)
Builds
Surgical devices and manufacturing processes
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality engineering, manufacturing quality, supplier quality, cross-functional project leadership, nonconformance investigation, root cause analysis, CAPA management, PPAP execution, process validation, equipment qualification, MSA, risk management, statistical process control, GD&T, metrology equipment operation, ISO 13485, GMP
Preferred skills
Quality systems management, audits, statistical data analysis, Six Sigma Green Belt or Black Belt certification
Technologies
CMMs, calipers, micrometers, pin gauges
Responsibilities
Support quality deliverables for new product launches and manufacturing transfers; Own nonconformance investigations and drive containment, root cause analysis, and corrective actions; Lead CAPA activities; Review and disposition nonconforming materials; Execute PPAP activities; Support process validation, equipment qualification, and MSA; Monitor quality metrics and drive continuous improvement.
Seniority
Staff, hands-on IC with strategic initiative leadership
