Manufacturing Quality Engineer - Process Improvement & CAPA

W. L. Gore & Associates, Inc.; Flagstaff (AZ); Sur place; USD 70 000 - 95 000; Plein temps

Résumé du poste

W. L. Gore & Associates, Inc.

is seeking an experienced Quality Engineer to join our Flagstaff, Arizona team. You will support commercialized product manufacturing, drive process improvements, perform quality determinations, and participate in installation, operation, maintenance and upgrade of production equipment and workflow. The role emphasizes hands-on problem solving, design history file maintenance, and compliance with ISO and global quality standards.

Qualifications

• Requires bachelor's degree in engineering and 1+ year in manufacturing support.
• Proficient in structured problem-solving methods (8D/8-Step/DMAIC/PDCA).
• Knowledge of Product Risk Management and risk mitigation.

Responsabilités

• Develop deep technical knowledge of product and documentation to support quality processes and CAPAs.
• Ensure compliance to ISO and global quality standards for design and performance.
• Own quality engineering design control deliverables and maintain Design History Files.
• Apply formal problem-solving to identify root causes of non-conformances and implement CAPAs.
• Identify opportunities to improve manufacturing processes and assess regulatory, safety, and cost impacts.
• Use statistical techniques to drive data-driven decisions and sampling plans.
• Collaborate with engineers on scale-up, validation, and improvement projects.
• Provide technical support for manufacturing of GORE CARDIOFORM devices.
• Support manufacturing, regulatory, and quality assurance in execution of work.
• Promote equitable and inclusive behaviors within the team.

Connaissances

Structured problem-solving (8D/DMAIC/5

Formation

Bachelor's degree in Engineering

Description du poste

W. L. Gore & Associates, Inc.

is seeking an experienced Quality Engineer to join our Flagstaff, Arizona team. You will support commercialized product manufacturing, drive process improvements, perform quality determinations, and participate in installation, operation, maintenance and upgrade of production equipment and workflow. The role emphasizes hands-on problem solving, design history file maintenance, and compliance with ISO and global quality standards.