Quality Engineer, Medical Devices | Process & Risk

W. L. Gore & Associates; Flagstaff (AZ); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work arrangement

Associate Stock Ownership Plan

Job summary

W. L. Gore & Associates in Flagstaff, AZ seeks a hands-on Quality Engineer to support medical device manufacturing, investigate nonconformances, and drive process improvements.

Hybrid work arrangement available; travel up to 5% may be required. This role partners across manufacturing, engineering, quality, supply chain, and regulatory to ensure product quality and risk management compliance, while improving yield and process capability through data-driven decisions.

Qualifications

• Bachelor’s degree in Engineering or Science required.
• Experience applying structured problem-solving methods (8D, DMAIC, or PDCA).
• Knowledge of product/process risk-management principles.
• Engineering fundamentals and statistical analysis applied to quality support.
• Ability to identify critical issues and recommend risk-based actions.
• Strong multi-project organization and cross-functional collaboration.
• Excellent documentation and communication of technical results.
• Up to 5% travel.

Responsibilities

• Maintain quality engineering, risk-management, and design-control documentation to support product requirements and continued compliance with applicable global requirements.
• Evaluate product and process nonconformances, providing risk-based recommendations for disposition and follow-up.
• Lead structured problem-solving and root-cause investigations, developing and implementing effective corrective and preventive actions.
• Apply engineering fundamentals, statistical analysis, and manufacturing data to support product-quality decisions and improve yield, capability, capacity, productivity, safety, and ergonomics.
• Establish and improve sampling plans, visual standards, test methods, and other quality controls.
• Support product and process changes, scale-up activities, test-method validation, and manufacturing validation.
• Develop strong product and process knowledge to support investigations, risk assessments, change control, audits, and continuous improvement.
• Collaborate with manufacturing, Quality Assurance, supply chain, regulatory, product specialists, and engineering partners to move work from problem identification through implementation.
• Clearly document and communicate technical conclusions, risks, recommendations, and project status to technical and nontechnical stakeholders.
• Contribute to an inclusive team environment where different perspectives are valued and used to achieve strong business and patient outcomes.

Skills

Nonconformance investigation

Structured problem-solving (8D/DMAIC/5

Education

Bachelor’s degree in Engineering or Science

Job description

W. L. Gore & Associates in Flagstaff, AZ seeks a hands-on Quality Engineer to support medical device manufacturing, investigate nonconformances, and drive process improvements.

Hybrid work arrangement available; travel up to 5% may be required. This role partners across manufacturing, engineering, quality, supply chain, and regulatory to ensure product quality and risk management compliance, while improving yield and process capability through data-driven decisions.