Supplier Quality Engineer

Role:
Supplier Quality Engineer

Location:

Bridgeport Area, CT Duration: 6-Month Contract Position Overview

We are seeking experienced Supplier Quality Engineers to support a medical device quality remediation initiative. This role will focus on supplier quality operations, remediation activities, quality system improvements, and supplier performance management within a regulated medical device environment.

The ideal candidate will have a strong background in supplier quality engineering, remediation projects, injection molding suppliers, and quality system processes including NCMRs, SCARs, and CAPAs.

• Support supplier quality remediation activities within a medical device manufacturing environment.
• Lead and manage supplier-related quality investigations, nonconformances, and corrective action initiatives.
• Review, develop, and maintain Supplier Quality documentation and records.
• Drive closure of supplier quality issues through effective root cause analysis and corrective actions.
• Manage and support:
• Nonconforming Material Reports (NCMRs)
• Supplier Corrective Action Requests (SCARs)
• Corrective and Preventive Actions (CAPAs)
• Collaborate with suppliers to improve quality performance and ensure compliance with regulatory requirements.
• Support supplier qualification, monitoring, and ongoing quality improvement initiatives.
• Partner with cross-functional teams including Quality, Manufacturing, Engineering, and Supply Chain.
• Ensure supplier quality processes align with QMS requirements and remediation objectives.
• Organize and maintain supplier quality documentation to support audit readiness and compliance efforts.

• 7+ years of Supplier Quality Engineering experience within the Medical Device industry.
• Proven experience supporting Quality System remediation projects from a Supplier Quality perspective.
• Hands‑on experience managing NCMRs, SCARs, CAPAs, and supplier quality investigations.
• Strong understanding of FDA Quality System Regulations and ISO 13485 requirements.
• Experience working with injection molding suppliers and manufacturing processes.
• Demonstrated experience developing, reviewing, and maintaining supplier quality documentation.
• Strong problem‑solving, root cause analysis, and communication skills.