Supplier Quality Engineer

Summary :
We are seeking an experienced Supplier Quality Engineer with a strong background in the Medical Device industry to support supplier quality, incoming inspection, and manufacturing quality initiatives.

Roles & responsibilities :

• Drive supplier quality and incoming inspection activities
• Analyze material non-conformances and work directly with suppliers on resolution
• Support component selection, qualification, and reliability assessments
• Review product designs for quality and manufacturability
• Lead supplier investigations, root cause analysis, and corrective actions

Education & Experience :

• 5+ years of experience in Manufacturing Engineering, Supplier Quality, or Quality Engineering within Medical Devices
• Hands-on experience with Supplier Quality Engineering, Receiving Inspection, and supplier management
• Experience with SAP (Quality/Supply Chain modules) or similar ERP systems
• Knowledge of Windchill or other document control systems for change management and BOM updates
• Experience developing inspection procedures, quality plans, and inspection tooling
• Ability to support component qualification, testing, validation, and approval activities
• Strong collaboration with Design Engineering on component quality, reliability, and manufacturability
• Experience investigating supplier-related quality issues, material defects, and corrective actions (CAPA)
• Knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971