Responsibilities

• Familiarity with FDA, ISO, and ANSI regulations and standards (e.g., ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 820, QMSR).
• Creates necessary procedures and forms to support the Quality Management system.
• Participates in internal, external, and 3rd party quality audits.
• Maintain data integrity and audit readiness of all NC records.
• Coordinate with Quality Engineering, Manufacturing, Supply Chain, and Supplier Quality to ensure effective investigation and disposition of Non-Conforming product/material.
• Provide guidance and training on proper NC initiation, documentation, and closure.
• Ensure timely progression of NCs through the workflow and escape overdue or stalled records.
• Verify electronic disposition in ERP systems aligns with physical inventory status.
• Generate and maintain metrics, including aging, cycle time, disposition trends, and recurrence.
• Identify patterns ...