Manager, Supplier Quality Engineering
Core
Lead Supplier Quality Engineers to manage supplier performance, drive continuous improvement, and ensure compliance with FDA and ISO standards for medical devices.
Role type
Senior Manager, Supplier Quality Engineering
Builds
Medical devices (AEDs, ventilators, temperature management solutions) for EMS, hospital, public safety, and military customers
Domain
Medical technology / Regulatory compliance (FDA, ISO 13485)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality management, root cause analysis, corrective action planning, supplier audits, performance metrics, team leadership, FDA QSR documentation, global supplier sourcing, validation of medical devices
Preferred skills
MBA, Six Sigma, Lean Manufacturing, ISO 9001/13485 expertise, PCB fabrication knowledge, MRP systems, automotive or military validation experience
Technologies
MS Office suite, Smartsheets, MRP systems
Responsibilities
Manage assigned Supplier Quality Engineering staff and mentor team members, conduct supplier performance reviews and improvement audits, investigate supplier defects and implement corrective actions, support new product introduction and vendor qualification, execute SQE strategy compliant with FDA requirements, report supplier quality status to management
Seniority
Manager, supervisory role with 5+ years management experience