Quality Engineer, Medical Device Manufacturing

W. L. Gore & Associates, Inc.; Phoenix (AZ); On-site; USD 85,000 - 120,000; Full time

Job summary

W. L. Gore & Associates, Inc. in Flagstaff, Arizona, is seeking an experienced Quality Engineer to support manufacturing, drive process improvements, and solve problems hands‑on while ensuring operator safety and quality.

The role involves owning quality design controls, maintaining Design History Files, applying CAPA methods, and collaborating with cross‑functional teams to meet ISO and global quality standards.

Qualifications

• Bachelor's degree in Engineering and minimum of 3 years of experience in manufacturing.
• Experience applying structured problem-solving approaches (8D/PDCA/DMAIC) to root-cause analysis.
• Knowledge in Product Risk Management and mitigation methods.
• Apply engineering fundamentals and statistical analysis to quality support and troubleshooting.
• Ability to manage multiple projects with timelines and commitments.
• Strong collaboration, mentoring abilities, and independent prioritization.
• Identify critical issues and perform risk-based decision making.
• Strong technical communication for documenting and presenting work.
• Willingness to work in a hands-on manufacturing environment.
• Ability to travel up to ~5%.

Responsibilities

• Develop deep knowledge of product documentation to support quality processes and root-cause discovery.
• Ensure ISO and global quality standards compliance and update documentation (FMEAs, ERT, PERC).
• Own quality design control deliverables and maintain Design History Files.
• Apply problem-solving techniques to non-conformances and implement CAPA plans.
• Identify opportunities to improve manufacturing processes and assess regulatory and safety impacts.
• Use statistics to guide sampling plans and continuous improvement.
• Collaborate with engineers across development cycles (scale-up, validation, improvement).
• Provide mentorship to ensure quality decisions on product release and supplier quality.
• Support manufacturing of Gore CARDIOFORM devices and coordinate with Quality.
• Coordinate with Assurance, Manufacturing, and Regulatory; promote inclusive behavior.

Skills

Structured problem-solving

Statistical analysis

Technical communication

Team collaboration

Mentoring

Education

Bachelor's degree in Engineering

Tools

FMEA

ERT

PERC

Job description

W. L. Gore & Associates, Inc. in Flagstaff, Arizona, is seeking an experienced Quality Engineer to support manufacturing, drive process improvements, and solve problems hands‑on while ensuring operator safety and quality.

The role involves owning quality design controls, maintaining Design History Files, applying CAPA methods, and collaborating with cross‑functional teams to meet ISO and global quality standards.