Director, Quality Programs-Integrated Supply Chain (ISC)
Core
Strategic leadership for enterprise and site-level quality programs within FDA regulated medical-device manufacturing environments, leading large scale global cross-functional programs to strengthen the quality management system and improve compliance.
Role type
Director, Quality Programs (Medical Device Manufacturing)
Builds
Quality management systems, compliance projects, and operational excellence initiatives for medical device supply chain.
Domain
Medical Device Manufacturing / Regulatory Compliance / Quality Assurance
Required skills
Strategic program management, FDA regulatory compliance, ISO 13485/14971 standards, GMP/GDP, Data analytics, Team leadership, Budgeting, Change management
Preferred skills
Six Sigma, PMP, Advanced degree
Technologies
AI tools, Data analytics platforms, Quality KPI dashboards
Responsibilities
Lead and mentor a team of Program Managers and data analysts; Develop and implement strategic plans for quality programs including AI integration; Oversee planning and execution of quality compliance projects; Ensure adherence to industry standards and regulatory requirements; Collaborate with Operations, Engineering, and Supply Chain departments; Prepare reports on project status and performance metrics to senior management; Drive continuous improvement initiatives.
Seniority
Director, Strategic Leadership
