Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, Documentation Review, Identify Issues, Leadership, Maintain Compliance, Manufacturing, Manufacturing Operations, Product Documentation, Quality Engineering, Quality Metrics, Regulations, Regulatory Compliance, Risk, Risk Analysis, Root Cause Analysis
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.