Quality Assurance Engineer

Position Summary

The Quality Engineer is responsible for supporting and improving the organization's Quality Management System through leadership of corrective actions, customer complaint investigations, audit activities, process improvement initiatives, and cross-functional quality programs.

This role serves as a key liaison between Quality, Engineering, Operations, Supply Chain, and Customer Service to ensure timely resolution of quality issues, effective implementation of corrective actions, and ongoing compliance with customer, regulatory, and quality management system requirements.

The Quality Engineer is expected to drive quality initiatives through influence, technical problem solving, data analysis, and project management while maintaining audit-ready documentation and objective evidence.

Core Responsibilities

Corrective Action & Investigation Leadership

• Lead customer complaint, internal nonconformance, supplier quality, and audit-related investigations.
• Facilitate root cause analysis activities using structured problem-solving methodologies.
• Coordinate corrective and preventive actions across departments.
• Track action item completion, effectiveness verification, and closure activities.
• Escalate overdue or ineffective corrective actions to management.
• Facilitate Material Review Board (MRB) activities, including disposition coordination, documentation, and implementation of containment actions.

Quality Systems & Compliance

• Support maintenance and continuous improvement of the Quality Management System.
• Coordinate internal, customer, and third-party audits.
• Assist with development and revision of quality procedures, forms, and work instructions.
• Support training initiatives related to quality system requirements.
• Maintain audit-ready objective evidence and quality records.

Customer & Supplier Quality Support

• Support customer quality requests, corrective actions, and quality reporting activities.
• Coordinate responses to customer complaints and audit findings.
• Manage supplier quality activities including supplier corrective actions (SCARs), supplier performance monitoring, and quality issue resolution.
• Assist with supplier qualification and monitoring activities.

Process Improvement & Quality Engineering

• Analyze quality data and trends to identify improvement opportunities.
• Support implementation of process controls and risk reduction activities.
• Participate in validation, verification, and process improvement projects.
• Support development of quality metrics and KPI reporting.
• Partner with Engineering and Operations to improve product and process performance.
• Support manufacturing and controlled environment operations by monitoring cleanroom quality systems, environmental controls, and compliance with applicable cleanroom procedures and customer requirements.