Quality Engineer

Responsibilities

• Pilot Manufacturing Support
• Serve as the primary Quality representative for Pilot manufacturing operations.
• Support daily production activities by ensuring quality requirements are understood and consistently applied.
• Partner with Manufacturing and Engineering to resolve production issues and implement corrective actions.
• Lead root cause investigations and drive effective corrective and preventive actions (CAPA).
• Review and disposition nonconforming material in collaboration with Engineering and Operations.
• Quality Management System
• Develop and maintain quality procedures, work instructions, forms, and records supporting Pilot operations.
• Implement quality processes aligned with ISO 9001 requirements, preparing Pilot to operate with certified-quality practices.
• Support document control, change management, record retention, and risk-based thinking throughout manufacturing.
• Participate in internal audits and management reviews and track actions to closure.
• Production Quality Planning
• Develop production quality plans and inspection requirements for Pilot manufacturing.
• Define Critical-to-Quality (CTQ) characteristics with Engineering and Manufacturing.
• Create and maintain Control Plans that define inspection points, sampling frequency, and acceptance criteria.
• Collaborate with the Metrology Lead and Analytical Lab Lead to ensure appropriate measurement methods are available.
• Digital Quality Systems
• Support implementation and continuous improvement of digital manufacturing and quality systems, including MES, ERP, LIMS, and the electronic Quality Management System (eQMS).
• Improve traceability and data integrity across manufacturing operations.
• Help define system requirements for inspections, deviations, nonconforming material, CAPA, document control, and production records and participate in software testing, validation, and user training.
• Continuous Improvement