Quality Engineer - NCE Remediation

Key Responsibilities

• Support a dedicated NCE Burn-Down Team responsible for reducing a backlog of 1,000+ open Nonconforming Events (NCEs) under regulatory scrutiny and warning letter remediation across multiple manufacturing product lines.
• Conduct thorough risk assessments, investigation activities, and root cause evaluations to determine appropriate disposition pathways and ensure compliant, timely closure of NCE records.
• Partner with Quality Technicians on containment actions, product disposition execution, and documentation review, allowing engineering focus on higher-level risk evaluation and corrective action development.
• Drive end-to-end NCE closure activities including problem identification, systemic impact assessment, disposition determination, CAPA recommendations, and correction implementation to prevent recurrence.
• Prepare complete NCE packages for Material Review Board (MRB) approval, ensuring investigations were technically sound, documentation was audit-ready, and review-board expectations were met.
• Manage high-volume execution targets in a fast-paced manufacturing environment, supporting closure of up to 2 NCEs per day / ~80 NCEs per week while maintaining quality and compliance standards.
• Collaborate cross-functionally with Quality, Manufacturing, and leadership teams to prioritize critical events, evaluate product impact, and support remediation efforts across all affected product dimensions.
• Contribute to regulatory risk reduction by ensuring thorough documentation, compliant investigation practices, and effective corrective actions for nonconforming material and process deviations.