Hybrid Quality Engineer - Medical Device Problem Solver

W. L. Gore & Associates, Inc.; Phoenix (AZ); Hybrid; USD 70,000 - 110,000; Full time

Job summary

W. L. Gore & Associates, Inc. in Phoenix, AZ is seeking an experienced Quality Engineer to support medical device manufacturing. This hands-on role focuses on quality, risk management, and process improvement across manufacturing, engineering, quality, and regulatory teams.

You will investigate nonconformances, drive corrective actions, apply statistics, and help improve yield, process capability, and safety. A hybrid remote option is available.

Qualifications

• Bachelor's degree in Engineering and 2+ years of post-graduate quality/manufacturing experience.
• Structured problem-solving approach (8D/ DMAIC/ PDCA) and root-cause tools (5 Whys, fishbone).
• Knowledge of risk-management principles and documentation.
• Apply engineering and statistics to product-quality support and process optimization.
• Identify critical issues and risk-based actions.
• Ability to manage multiple projects against timelines.
• Work independently while collaborating with cross-functional teams.
• Excellent documentation and communication of technical conclusions.
• Willingness to travel up to 5%.

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

Quality engineering

8D / DMAIC / PDCA

Root-cause analysis

Risk management

Statistical analysis

Engineering fundamentals

Cross-functional collaboration

Independent work

Documentation & communication

Travel up to 5%

Education

Bachelor's degree in Engineering

Job description

W. L. Gore & Associates, Inc. in Phoenix, AZ is seeking an experienced Quality Engineer to support medical device manufacturing. This hands-on role focuses on quality, risk management, and process improvement across manufacturing, engineering, quality, and regulatory teams.

You will investigate nonconformances, drive corrective actions, apply statistics, and help improve yield, process capability, and safety. A hybrid remote option is available.