Supplier Quality Associate

We are seeking a Supplier Quality Associate to support supplier quality activities within a regulated medical device manufacturing environment. The ideal candidate will work closely with Quality, Supply Chain, Manufacturing, Engineering, and Purchasing teams to ensure suppliers meet established quality and regulatory requirements.

This role will support supplier qualification, supplier performance monitoring, nonconformance investigations, supplier corrective actions, audits, and quality system compliance activities.

• Support supplier qualification, onboarding, and approval activities.
• Maintain supplier quality records, documentation, and Approved Supplier List (ASL).
• Support Supplier Corrective Action Requests (SCARs) from investigation through closure.
• Monitor supplier performance through quality metrics, scorecards, and performance reviews.
• Assist with supplier nonconformance investigations and resolution activities.
• Support root cause analysis and corrective action implementation.
• Review supplier documentation for compliance with internal quality procedures and regulatory requirements.
• Participate in supplier audits, audit preparation, findings follow-up, and closure activities.
• Support CAPA, nonconformance, and supplier-related quality system activities.
• Collaborate with Engineering, Manufacturing, Purchasing, Supply Chain, and Quality teams to resolve supplier quality issues.
• Support supplier risk assessments, PFMEA reviews, and risk-based supplier controls.
• Assist with remediation and continuous improvement activities related to supplier controls.
• Maintain accurate supplier quality documentation in accordance with applicable procedures and regulations.
• Support supplier performance reporting, quality metrics, and management review activities.
• Identify opportunities to improve supplier quality processes and controls.

Required Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related discipline.
• 3–8 years of experience in medical device, pharmaceutical, or other regulated manufacturing environments.
• Experience with Supplier Quality and Supplier Controls.
• Hands-on experience with CAPA, SCARs, Nonconformance Management, and Root Cause Analysis.
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Strong documentation, communication, analytical, and technical writing skills.

Preferred Qualifications

• Experience conducting or supporting supplier audits.
• Experience with Approved Supplier Lists (ASL) and supplier scorecards.
• Knowledge of PFMEA and risk assessments.
• Experience with Track Wise, Windchill, Agile, SAP, ETQ, or similar quality management systems.
• Experience working in a highly regulated medical device or life sciences environment.