Biology, Corrective and Preventative Action (CAPA) Systems, Design Failure Mode and Effects Analysis (DFMEA), Engineering, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Manufacturing, Medical Equipment, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Quality Engineering, Quality Management, Risk, Risk Analysis, Risk Management, Root Cause Analysis, Technical Support, Vendor/Supplier Evaluation
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.