Staff Engineer Quality Process
Core
Provide quality engineering leadership and direction in quality assurance, control, and preventative activities to ensure product and process quality performance.
Role type
Staff Quality Process Engineer
Builds
Manufacturing processes and quality systems for medical devices
Domain
Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management, CAPA, audits, statistics, change management, inspection methods, sampling, validation strategies, regulatory compliance, problem-solving, root-cause analysis
Preferred skills
Six Sigma Green/Black belt, new production line launches, regulatory agency interaction, matrix organization management
Technologies
ISO 13485, GDP, GMP
Responsibilities
Lead investigations during concession management, interpret KPI trends to drive continuous improvement, engage in internal and external audits, support manufacturing transfers, initiate product holds for potential escapes, mentor others in quality topics
Seniority
Staff, hands-on IC with mentorship
