Supplier Quality Engineer
Katalyst HealthCares & Life Sciences
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
Vacancy posted 4 days ago
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