Quality Engineer – NCE Remediation

Key Responsibilities:

• Support an NCE (Nonconforming Event) remediation team focused on reducing a large backlog of open quality events under regulatory scrutiny and remediation initiatives.
• Perform risk assessments, investigations, root cause analysis, and determine appropriate disposition paths for NCE closure.
• Work closely with Quality Technicians on containment actions, product disposition, and documentation review activities.

Drive end-to-end NCE closure activities including:

• Problem identification

• Risk/systemic impact assessments

• Disposition recommendations

• CAPA recommendations

• Corrective action implementation

• Prepare investigation and NCE documentation packages for MRB (Material Review Board) review and approval.

• Support high-volume execution in a fast-paced manufacturing environment while maintaining compliance and documentation quality.

• Collaborate with cross-functional teams including Quality, Manufacturing, and Operations leadership.

• Ensure audit-ready documentation and compliance with regulatory and quality standards.