Supplier Quality Specialist

Overview

A leading regulated manufacturing organization is seeking a Supplier Quality Specialist to support supplier quality and compliance initiatives. This role will focus on reviewing supplier audit findings, managing Supplier Corrective Action Requests (SCARs), evaluating CAPAs, and maintaining quality documentation within an electronic Quality Management System (eQMS).

Key Responsibilities

• Manage and track approximately 400 Supplier Corrective Action Requests (SCARs) annually.
• Review supplier responses, audit findings, root cause analyses, corrective actions, and preventive actions.
• Evaluate CAPA effectiveness, verification plans, and compliance with quality system requirements.
• Monitor corrective action progress and escalate overdue or ineffective actions.
• Support supplier audit planning, audit documentation, and audit follow-up activities.
• Ensure audit findings are properly documented and transitioned into SCAR processes when needed.
• Maintain supplier quality records and documentation within eQMS platforms.

Required Skills

• 3 years of experience in Supplier Quality, Quality Assurance, Compliance, or Quality Systems.
• Experience with supplier audits, SCARs, and CAPA processes.
• Ability to review audit reports and assess quality system or regulatory nonconformances.
• Strong understanding of root cause analysis and corrective/preventive action methodologies.
• Experience with eQMS platforms such as Arena, Agile, MasterControl, Veeva, TrackWise, or similar systems.
• Strong organizational and communication skills.

Plusses

• ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification.
• Experience in medical device, pharmaceutical, biotech, or other regulated industries.
• Knowledge of FDA, ISO 13485, or ISO 9001 standards.