The Supplier Quality Specialist is responsible for managing, evaluating, and monitoring supplier quality performance within a regulated Class III medical device environment in compliance with ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820/QMSR, and internal quality system requirements.

This role plays a critical part in supplier qualification, supplier audits, nonconformance management, CAPA activities, supplier change control, and continuous improvement initiatives to ensure product safety, compliance, and reliability.

Responsibilities

• Qualify, approve, and maintain critical and strategic suppliers.
• Conduct supplier risk assessments in accordance with ISO 14971 requirements.
• Support supplier selection activities in collaboration with Purchasing, Operations, Manufacturing, and R&D teams.
• Conduct periodic supplier performance reviews and escalation activities when necessary.
• Plan and perform supplier quality ...