Sr. Manager, Quality Engineering
Core
Lead a team of engineers and technicians to investigate product failures, identify root causes, and implement corrective actions to ensure product reliability and quality for medical devices.
Role type
Senior Manager, Quality Engineering (Failure Analysis)
Builds
Robust failure analysis tools, processes, and CAPA programs for medical device products.
Domain
Medical Technology / Quality Engineering / Failure Analysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Failure analysis, root cause analysis, Six Sigma, Lean Manufacturing, project management, team leadership, regulatory compliance (FDA/GMP/ISO), statistical process control, design of experiments, data analytics
Preferred skills
Cross-functional collaboration, talent development, strategic planning, metrics integration
Technologies
Microsoft Office Suite, failure analysis tools, statistical software
Responsibilities
Manage project activities and deliverables using engineering methods; develop failure analysis tools and processes; manage and oversee assigned teams; lead CAPA program implementation; resolve operational and scheduling issues; interact with production supervisors, customers, and peer managers.
Seniority
Senior, hands-on IC with management responsibilities
