Senior Quality Engineer, Pilot Manufacturing & ISO 9001

Vulcan Elements Inc.

Durham (NC)

In loco

USD 90.000 - 140.000

Tempo pieno

39 ore fa

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Descrizione del lavoro

Vulcan Elements Inc. is seeking a Sr.

Quality Engineer to establish robust quality processes at the Pilot manufacturing facility and drive ISO 9001-aligned operations for rapid product development. You will collaborate across Manufacturing, R&D, Process Engineering, Analytical Lab and Quality to implement production quality plans, CTQs, control plans and digital quality systems, enabling scalable transfer to Benson.

Competenze

Bachelor's degree or higher in Engineering, Materials Science, Manufacturing Engineering, Industrial Engineering, or related field.
3+ years of experience in manufacturing quality, production engineering, or quality systems.
Experience with ISO 9001 principles and quality management systems.
Experience supporting production operations in a manufacturing environment.
Experience writing SOPs, work instructions, and manufacturing documentation.
Experience with root cause analysis and corrective actions.
Strong analytical, organizational, and communication skills.

Mansioni

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 CAPA actions.
Review and disposition nonconforming material with Engineering and Operations.
Develop and maintain quality procedures, work instructions, forms, and records.
Implement quality processes aligned with ISO 9001 requirements and prepare Pilot to operate with certified-quality practices.
Support document control, change management, record retention, and risk-based thinking across manufacturing.
Participate in internal audits and management reviews and track actions to closure.
Develop production quality plans and inspection requirements for Pilot manufacturing.
Define CTQ characteristics with Engineering and Manufacturing.
Create and maintain Control Plans with inspection points and acceptance criteria.
Collaborate with Metrology Lead and Analytical Lab Lead on measurement methods.
Support implementation and continuous improvement of digital manufacturing and quality systems, including MES, ERP, LIMS, and 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 and validation.
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 to improve product quality, process consistency, efficiency, and traceability.
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.