Ingeniero De Sistemas De Calidad Nc Emi

ResponsibilitiesFamiliarity with FDA, ISO, and ANSI regulations and standards (e.g., ISO ****, ISO *****, ISO *****, 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 or systemic issues and recommend improvements.Contribute to updates of NC procedures, forms, and work i...