Quality Engineer: Process Improvement & CAPA

W. L. Gore & Associates, Inc.; Flagstaff (AZ); On-site; USD 85,000 - 115,000; Full time

Job summary

Gore is seeking an experienced Quality Engineer to join our team in Flagstaff, Arizona. You will support commercialized product manufacturing, drive process improvements, and help ensure operator safety while assisting with equipment installation, maintenance, and upgrades.

You will apply structured problem solving, maintain Design History Files, and collaborate with Quality Assurance, Manufacturing, and Regulatory to release products such as CARDIOFORM Occluders.

Qualifications

• Bachelor's Degree in Engineering with at least 3 years of hands-on engineering experience.
• Experience with structured problem-solving approaches (8D, 8-Step, DMAIC or PDCA) that drive root cause analysis.
• Knowledge of Product Risk Management (risk identification, analysis, and mitigation).
• Ability to apply engineering fundamentals and statistics to quality support, optimization, and troubleshooting.
• Ability to manage multiple projects concurrently from development to completion.
• Ability to work in teams, mentor others, and drive projects to completion.
• Ability to identify critical issues and perform risk-based decisions.
• Ability to document, communicate, and present technical work.
• Willingness to travel up to 5%.

Responsibilities

• Develop deep technical and historical knowledge of the product/documentation to support quality processes and drive root-causes in non-conformance and CAPAs.
• Ensure continued compliance to ISO and other global quality standards/guidelines for product design and performance, addressing documentation gaps and updates.
• Own quality engineering design control deliverables and maintain Design History Files.
• Apply formal problem-solving techniques to determine root cause and implement CAPA plans.
• Identify opportunities to continuously improve manufacturing processes and assess various impacts.
• Employ statistical techniques to promote data-driven decisions and establish sampling plans.
• Partner with other engineers across development cycles for scale-up, validation, and improvement.
• Provide technical support for manufacturing of Gore cardioform devices and collaborate with QA, Manufacturing, and Regulatory.
• Mentor others and ensure quality decisions in product release and supplier quality.
• Practice equitable and inclusive behaviors with associates to achieve results.

Skills

Structured problem-solving

8D / DMAIC

Root cause analysis

Statistical analysis

Documentation & DHF

Collaborative teamwork

Travel readiness

Education

Bachelor's Degree in Engineering

Job description

Gore is seeking an experienced Quality Engineer to join our team in Flagstaff, Arizona. You will support commercialized product manufacturing, drive process improvements, and help ensure operator safety while assisting with equipment installation, maintenance, and upgrades.

You will apply structured problem solving, maintain Design History Files, and collaborate with Quality Assurance, Manufacturing, and Regulatory to release products such as CARDIOFORM Occluders.