Supplier Quality Engineer

Salary: $65,000 – $115,000+ (Based on Experience)

Schedule: Monday–Friday, 7:00/8:00 AM – 4:00/5:00 PM

Travel: Approximately 10–20% Domestic & International

Openings: 3 Positions Available

We are actively seeking both Supplier Quality Engineers (SQE) and Senior Supplier Quality Engineers (Sr. SQE) to support supplier quality initiatives within a growing medical device manufacturing environment. These positions play a critical role in supporting both New Product Introduction (NPI) and sustaining manufacturing operations by ensuring supplier compliance, quality performance, and regulatory adherence throughout the supply chain.

The ideal candidates will serve as key liaisons between Engineering, Procurement, Manufacturing, Quality, customers, and suppliers to ensure materials, components, and services consistently meet quality, regulatory, and performance expectations.

• Support or lead supplier qualification activities for New Product Introduction (NPI) projects
• Conduct risk-based supplier assessments and evaluations
• Participate in supplier selection activities alongside Engineering, Procurement, and Quality teams
• Perform supplier audits (onsite and remote) for qualification and surveillance purposes
• Review supplier certifications, quality records, validation documentation, and compliance records
• Support supplier readiness activities for production launch, including process evaluations and quality system assessments
• Participate in design transfer activities and process validation efforts involving suppliers
• Evaluate supplier manufacturing capabilities, capacity, quality systems, and process controls
• Monitor supplier performance through quality metrics, delivery performance, defects, and SCAR activity
• Lead or support Supplier Corrective Action Requests (SCARs), CAPA investigations, and closure activities
• Conduct supplier performance reviews and drive continuous improvement initiatives
• Support containment activities, root cause investigations, and resolution of supplier-related quality issues
• Perform supplier re-evaluations and periodic risk-based assessments
• Maintain strong supplier relationships while driving accountability and quality performance
• Ensure supplier compliance with ISO 13485, FDA Quality System Regulations, and applicable quality requirements
• Maintain and improve Approved Supplier List (ASL) processes and supplier risk classifications
• Support internal audits, customer audits, and regulatory inspections involving supplier quality systems
• Ensure supplier quality agreements are established and maintained
• Support change notification management and supplier control processes
• Partner with Engineering, Manufacturing, Procurement, Quality Assurance, and customer design teams
• Support material nonconformance investigations and disposition decisions
• Provide supplier risk assessments and recommendations to project teams
• Participate in change control and risk mitigation activities
• Support supply continuity planning and supplier development initiatives

• Bachelor’s Degree in Engineering, Life Sciences, or related technical discipline; equivalent experience may be considered
• Supplier Quality Engineer: 1–3 years of Supplier Quality, Quality Engineering, Manufacturing Quality, or related regulated industry experience
• Senior Supplier Quality Engineer: 3–5+ years of Supplier Quality or Quality Engineering experience within medical device or regulated manufacturing environments
• Strong knowledge of ISO 13485 and medical device quality systems
• Knowledge of FDA Quality System Regulations (21 CFR Part 820)
• Experience with supplier qualification, supplier audits, supplier development, and supplier performance management preferred
• Experience supporting New Product…