Supplier Quality Engineer

Seeking a Supplier Quality Engineer (5–8 years of experience) to support FDA remediation activities following a Warning Letter. The role focuses on supplier risk classification, supplier control improvements, FMEA alignment, supplier process validation, and remediation efforts related to legacy systems and acquired businesses.

• Classify supplier risk using severity, occurrence, and detection criteria, with emphasis on medium-to-high severity risks and zero-tolerance occurrences.
• Implement and strengthen supplier controls; evaluate supplier process capability and inspection effectiveness.
• Review DFMEAs and PFMEAs to ensure alignment with supplier manufacturing processes and controls.
• Identify gaps resulting from acquisitions and legacy systems; recommend risk rating adjustments based on supplier performance and controls.
• Support and/or execute IQ/OQ/PQ validation activities for supplier processes.
• Investigate and troubleshoot supplier nonconformances and quality issues.
• Serve as the technical quality representative for supplier interactions.
• Support FDA remediation projects and supplier quality improvement initiatives.

• 5–8 years of Supplier Quality Engineering experience in FDA-regulated industries, preferably medical devices.
• Experience supporting FDA inspections, Warning Letter remediation, and regulatory compliance initiatives.
• Strong knowledge of supplier quality management, DFMEA, PFMEA, risk assessments, and supplier controls.
• Experience with CAPA investigations, root cause analysis, and corrective actions.
• Hands‑on experience with IQ/OQ/PQ process validations.