Director, Quality Center of Expertise – Design Quality
Core
Lead enterprise Design Quality strategy, standards, and governance to ensure regulatory readiness and consistent execution across Medtronic's global medical device portfolio.
Role type
Director, Quality Center of Expertise – Design Quality
Builds
Enterprise Design Quality practices, shared services, and capability for implantable devices, software, and combination products.
Domain
Medical Devices / Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Enterprise quality strategy, Design Quality standards, regulatory readiness (FDA/EU MDR), matrix leadership, talent development, risk-based decision-making, process governance, KPI management, cross-functional alignment.
Preferred skills
ISO 13485, GMP, QMSR knowledge, Green/Black Belt certification, AI-enabled tool fluency, prompt engineering.
Technologies
AI-enabled tools, prompt writing frameworks
Responsibilities
Develop and execute enterprise Design Quality strategy and governance model; Establish and uphold Design Quality standards for global product portfolio; Own enterprise Design Quality KPIs and performance management; Lead real-time critical process governance for high-priority programs; Provide expert coaching and shared services to Operating Units; Deploy common Design Quality practices across complex technologies; Partner on large-scale initiatives to improve product development and quality effectiveness; Build enterprise capability through talent development and learning pathways; Influence decisions with enterprise-wide impact on product safety and brand reputation.
Seniority
Director, enterprise leadership
