Quality Engineer
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
Analyze production quality data to identify trends and improvement opportunities.
Develop dashboards and quality metrics to monitor Pilot performance.
Support standardization of manufacturing processes and best practices.
Drive projects that improve product quality, process consistency, efficiency, and traceability.
Manufacturing Readiness
Help prepare Pilot processes for successful transfer to Benson manufacturing.
Document lessons learned and best practices.
Support development of scalable production documentation and training materials.
Partner with Manufacturing and Engineering to improve production readiness.