Hybrid Quality Engineer - Medical Devices & Process Improvement

W. L. Gore & Associates; Arizona; Hybrid; USD 90,000 - 120,000; Full time

Job summary

W. L. Gore & Associates is seeking a Quality Engineer to provide hands-on quality engineering support for medical device manufacturing.

You will investigate nonconformances, improve yield and process capability, and maintain quality and risk-management documentation, collaborating across manufacturing, engineering, quality, supply chain, and regulatory to drive sustainable improvements. This position is located at our Flagstaff, Arizona facility with a hybrid work arrangement.

Qualifications

• Bachelor’s degree in Engineering or Science required.
• 5+ years post-graduate engineering or quality/manufacturing experience.
• Structured problem-solving methods (8D, DMAIC, PDCA) required.
• Knowledge of risk-management principles and documentation.
• Ability to apply statistics to product-quality support and process optimization.
• Ability to identify failure modes and risk-based actions.
• Ability to manage multiple projects with deadlines.
• Ability to work independently and influence cross-functional teams.
• Willingness to travel up to 5%.

Responsibilities

• Maintain quality documentation to support product requirements and compliance.
• Evaluate nonconformances and provide risk-based disposition.
• Lead root-cause investigations and implement CAPAs.
• Apply statistics to improve yield and process capability.
• Develop sampling plans, test methods, and quality controls.
• Support changes, scale-up, and validation activities.
• Collaborate across functions to move work from problem to solution.
• Communicate technical conclusions to stakeholders.
• Contribute to an inclusive, high-performing team.
• Travel up to 5%.

Skills

Structured problem-solving

Root-cause analysis

Statistical analysis

Cross-functional collaboration

Project management

Communication

Independent work

Documentation

Education

Bachelor’s degree in Engineering or Science

Tools

8D/ DMAIC/ PDCA

5 Whys / Fishbone

Job description

W. L. Gore & Associates is seeking a Quality Engineer to provide hands-on quality engineering support for medical device manufacturing.

You will investigate nonconformances, improve yield and process capability, and maintain quality and risk-management documentation, collaborating across manufacturing, engineering, quality, supply chain, and regulatory to drive sustainable improvements. This position is located at our Flagstaff, Arizona facility with a hybrid work arrangement.