Supplier Quality Engineer

• Lead supplier quality lifecycle management including supplier assessment, qualification, and ongoing performance monitoring.
• Develop and implement incoming inspection procedures, acceptance criteria, and train inspectors for compliance.
• Support test method validation, process validations (machine components & injection molded parts), and drive Gage R&R studies.
• Partner with Design Engineering to provide input on new technologies, component reliability, and manufacturability.
• Generate and maintain test protocols, qualification reports, and inspection tools/equipment.
• Drive root cause analysis and corrective actions for incoming material defects, yield issues, and field failures.
• Investigate supplier-related failures and implement corrective action plans.
• Ensure adherence to FDA regulations, corporate quality policies, and industry standards.

• Bachelor's degree in Engineering or related field with 4 6 years of relevant experience or Master's.
• Prior experience in the medical device industry is highly preferred.
• Proven ability to manage suppliers, ensure compliance, and drive quality improvements.

• Supplier Management & Relationship Building.
• Test Method Validation (TMV).
• Process Validation (manufacturing & injection molding).
• Strong knowledge of FDA regulations and ISO 13485.

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