Spec 3, Quality Assurance

Bill Rate ***
On site 5 days
Education Bachelor Engineering or Quality

Job Summary

The Supplier Quality Analyst is responsible for ensuring that suppliers of materials, components, and services used in medical devices consistently meet quality, regulatory, and risk requirements. This role supports compliance with FDA Quality System Regulation (21 CFR 820), ISO 13485 through supplier performance monitoring, corrective action management, and risk-based supplier controls.

Key Responsibilities

• Manage and maintain supplier qualification, monitoring, and re-evaluation activities in accordance with 21 CFR 820.50 (Purchasing Controls) and ISO 13485.


• Monitor supplier quality performance using KPIs such as defect rates, corrective action trends, and supplier risk levels.


• Maintain approved supplier lists (ASL) and supp...