Supplier Quality Engineer

We are seeking an experienced Supplier Quality Engineer (SQE) to support active FDA Warning Letter remediation efforts
. This role will focus on supplier risk classification, control enhancement, and risk alignment between DFMEAs, PFMEAs, and supplier manufacturing processes.

Following multiple acquisitions, legacy DFMEAs and supplier controls are not consistently aligned with current product and process risk levels. This position will work directly with suppliers to strengthen controls for medium-to-high risk failure modes
, improve process capability and inspection effectiveness, and support ongoing remediation activities while temporarily back filling an internal FTE.

This is a hands‑on, execution‑focused role requiring strong technical judgment, supplier engagement, and comfort operating in a highly regulated, high‑visibility environment.

• Classify supplier risk based on severity, occurrence, and detection
  , with emphasis on medium‑to‑high severity failure modes and zero‑tolerance occurrence risks
• Implement and assess enhanced supplier controls to mitigate identified risks
• Evaluate supplier process capability
  , inspection strategies, and control effectiveness

• Review DFMEAs and PFMEAs to assess alignment with supplier manufacturing processes
• Identify gaps resulting from legacy systems following acquisitions
• Recommend and justify risk rating updates based on actual supplier performance, controls, and historical data
• Ensure risk documentation accurately reflects current supplier processes and controls

• Support or execute IQ/OQ/PQ activities for supplier manufacturing processes
• Support troubleshooting of supplier nonconformances
  , including investigation and containment
• Provide technical input into supplier corrective actions and control improvements
• Serve as a technical quality representative to suppliers
• Work directly with supplier quality, manufacturing, and engineering teams to drive remediation actions
• Support supplier communication related to risk, controls, and compliance expectations

• 5–8 years of Supplier Quality Engineering experience in a regulated medical device environment
• Strong hands‑on experience with:
  • DFMEA and PFMEA review and alignment
  • Supplier process controls and inspection strategies
  • Experience supporting or executing process qualification activities (IQ/OQ/PQ)
• Proven ability to work directly with suppliers to resolve quality and compliance issues
• Strong technical judgment and documentation skills
• Comfortable operating in a high‑pressure remediation environment

• Direct involvement in FDA inspections or Warning Letter remediation
• Experience with CAPA investigations
  , root cause analysis, and effectiveness checks
• Experience working in post‑acquisition or legacy system environments
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and risk management standards