Supplier QA Engineer II - External Operations ENDO
Core
Ensures quality of sourced finished medical devices (SFMD) by managing supplier audits, resolving quality issues, and supporting new product onboarding for the Endoscopy division.
Role type
Supplier Quality Engineer (Medical Devices)
Builds
Sourced Finished Medical Devices (Single-Use Devices, Capital Equipment, accessories)
Domain
Medical Devices / Endoscopy
Deliverable
client delivery
Required skills
Supplier audit planning and execution, root cause analysis, corrective action plan review, regulatory compliance (ISO 13485, FDA), change impact assessment, complaint investigation, project management
Preferred skills
On-site supplier evaluation, cross-functional collaboration, continuous improvement methodologies
Technologies
Quality management systems, audit tools, regulatory databases
Responsibilities
Plan and lead supplier audits to assess compliance with regulatory standards; evaluate and resolve quality issues using systematic problem-solving; investigate complaints and manage NCEPs at suppliers; support new product development by onboarding suppliers and generating quality plans; lead or support internal and external regulatory audits; manage sustaining quality issues and process changes.
Seniority
Mid-level, hands-on IC