Job Description
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.
- Pl...