Senior Quality Systems Specialist
Core
Primary interface between Medtronic and external customers, owning and optimizing Quality Management System (QMS) processes for customer-related activities including orders, changes, complaints, and RMAs.
Role type
Senior Quality Systems Specialist (Customer-Focused)
Builds
Customer-facing quality processes, order management workflows, and change management procedures aligned with ISO 13485 and FDA requirements.
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
QMS process ownership, ISO 13485 compliance, FDA regulatory knowledge, customer complaint handling, RMA management, SAP order/shipment transaction management, change management, cross-functional collaboration, metrics tracking and reporting
Preferred skills
SAP configuration expertise, experience with customer portals, analytical skills for process improvement, stakeholder management
Technologies
SAP, MES, QMS documentation systems
Responsibilities
Optimize QMS frameworks for customer activities; establish and improve metrics for order performance and service quality; create and maintain QMS documentation; serve as SME during audits; manage customer orders, forecasts, and commitments in SAP; execute change management for customer requests; field and resolve customer complaints and RMAs; coordinate with Planning, Engineering, and Finance for issue resolution and reporting
Seniority
Senior, hands-on IC