Supplier Quality Engineer
Core
Ensures supplier quality compliance, executes APQP/PPAP processes, and manages supplier audits and corrective actions for medical device manufacturing.
Role type
Supplier Quality Engineer
Builds
Approved Supplier List, validated processes, and compliant supplier quality systems
Domain
Medical Devices / Quality Engineering
Required skills
APQP, PPAP, PFMEA, SPC, SCAR management, supplier audits, regulatory compliance (ISO 13485, 21 CFR), defect analysis, root cause analysis
Preferred skills
Six Sigma, DfX, data analytics for KPIs, risk assessment
Technologies
MSA, FAI, IQ/OQ/PQ, ISO 14971
Responsibilities
Conduct supplier audits for qualification and compliance; Execute APQP/PPAP deliverables including process validation; Manage SCARs and drive corrective/preventive actions; Qualify new suppliers for the Approved Supplier List; Analyze non-conformances and support supplier improvement initiatives.
Seniority
Entry-level to Mid-level, hands-on IC