Quality Engineering Manager
Core
Manage site quality systems, quality control/assurance inspections, and process audits for medical device manufacturing to ensure compliance and product release.
Role type
Quality Engineering Manager (Medical Devices)
Builds
Medical device valve assemblies and components
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People management, internal audit program management, external regulatory agency inspection management, project management, Six Sigma, Lean Manufacturing, cGMP compliance, FDA/ISO regulatory knowledge, financial acumen, design of experiments, statistical process control, failure mode and effects analysis
Preferred skills
Advanced Excel, talent development planning, cross-functional negotiation, budgetary management, change management
Technologies
Microsoft Office Suite, Six Sigma, Lean Manufacturing
Responsibilities
Manage supervisors and quality assurance teams; oversee process audits and final product release documentation; lead CAPA programs and failure investigations; collaborate on inspection of in-process and finished goods; develop talent development plans; integrate quality metrics into operations.
Seniority
Manager, people leadership & operational oversight