Associate Director, Device Supplier Management
Core
Lead Device Supplier Management and Purchasing Controls for medical devices and combination products to ensure cGMP compliance and quality.
Role type
Associate Director, Device Supplier Quality Management
Builds
Supplier qualification processes, quality agreements, and purchasing control frameworks for early commercialization programs.
Domain
Medical Devices / Regulatory Compliance / Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier Quality Management, Purchasing Controls, GMP Auditing, Regulatory Compliance, Risk Management, Supplier Relationship Management, Design Controls, Quality Management Systems (QMS), Manufacturing Processes, Strategic Planning
Preferred skills
FDA 21 CFR Part 4 & 820, EU MDR, ISO 13485, Medical Device Combination Products, Supplier Auditing
Technologies
SAP, Veeva Vault, Supplier Management Systems
Responsibilities
Lead supplier qualification, evaluation, and performance monitoring; develop and implement purchasing controls for early commercialization; support supplier audits as a Medical Device SME; partner on investigations for supplier-caused deviations; integrate purchasing controls into project plans; define device specifications and requirements for suppliers.
Seniority
Senior, hands-on IC with strategic planning capabilities