Quality Engineer – Manufacturing & Process Improvement

wlgore; Flagstaff (AZ); On-site; USD 95,000 - 125,000; Full time

Job summary

GORE is seeking an experienced Quality Engineer to support manufacturing of Cardioform devices at our Flagstaff, AZ facility. You will drive quality processes, support ISO compliance, CAPA, and problem-solving across design, production, and supplier quality. This is a hands-on role focused on safety, process improvements, and data-driven decisions.

Collaborate with cross-functional teams to ensure product release readiness and robust quality systems. Occasional travel may be required up to 5%.

Qualifications

• Bachelor's degree in Engineering and minimum of 3 years of experience supporting a manufacturing environment.
• Structured problem-solving approach (8D, 8-Step, DMAIC or PDCA) driving root cause analysis using 5-Why, Why Trees, and Fishbone.
• Knowledge in Product Risk Management (risk identification, analysis, mitigation).
• Apply engineering fundamentals and statistical analysis to product quality support, optimization and troubleshooting.
• Ability to manage multiple projects simultaneously and meet timelines.
• Strong technical communication skills for documenting and presenting technical work.
• Willingness to work in a hands-on manufacturing environment and travel up to ~5%.

Responsibilities

• Develop deep technical knowledge of product and documentation to support quality processes (audit, change control) and drive root-cause discovery in non-conformances and CAPAs.
• Ensure compliance to ISO and global quality standards for product design and performance.
• Own quality design control deliverables and maintain Design History Files.
• Apply problem-solving techniques to determine root cause and implement CAPA plans.
• Identify opportunities to improve manufacturing processes and assess regulatory, quality, ergonomic, safety, environmental, and cost impacts.
• Use statistical techniques to promote data-driven decisions for sampling plans and continuous improvement.
• Collaborate with engineers on scale-up, validation, and improvement projects.
• Provide mentorship and technical support to ensure quality decisions for product release and supplier quality.
• Support manufacturing of GORE CARDIOFORM devices with cross-functional collaboration.
• Practice equitable and inclusive behaviors with Associates to achieve outstanding results.

Skills

Structured problem-solving (8D/ DMAIC/

Product risk management

Engineering fundamentals & statistics

Strong technical communication

Multitasking / project management

Education

Bachelor's degree in Engineering

Job description

GORE is seeking an experienced Quality Engineer to support manufacturing of Cardioform devices at our Flagstaff, AZ facility. You will drive quality processes, support ISO compliance, CAPA, and problem-solving across design, production, and supplier quality. This is a hands-on role focused on safety, process improvements, and data-driven decisions.

Collaborate with cross-functional teams to ensure product release readiness and robust quality systems. Occasional travel may be required up to 5%.