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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

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