Job Title: Supplier Quality Engineer (SQE)
Locations: Massachusetts
Duration: 6+ Months Contract
Type: W2 Contract
Industry: Medical Devices / Life Sciences
Job Summary:
We are actively hiring "Supplier Quality Engineers" (SQEs) to support a high-priority FDA Remediation Project following an FDA Warning Letter. This opportunity is ideal for professionals with strong experience in Supplier Quality, CAPA, Risk Management, FMEA, FDA Compliance, and Medical Device Manufacturing.
Key Responsibilities:
• Supplier Risk Classification & Risk Assessment
• FDA Remediation & Supplier Quality Improvement
• DFMEA, PFMEA & Risk Management
• Supplier Process Validation (IQ/OQ/PQ)
• CAPA, Root Cause Analysis & Nonconformance Investigation
• Supplier Audits, Technical Support & Quality Compliance
Requirements:
• 5–8 years of Supplier Quality Engineering experience in Medical Devices.
• Experience supporting FDA Inspections, Warning Letter Remediation, or FDA Compliance projects.
• Strong knowledge of DFMEA, PFMEA, CAPA, Root Cause Analysis, Supplier Quality, and IQ/OQ/PQ.
• Bachelor's Degree in Engineering or a related technical discipline.