W. L. Gore & Associates · 1 day ago
Quality Engineer
Flagstaff, AZ
Full-time
Onsite
Mid Level
3+ years expW. L. Gore & Associates is looking for an experienced Quality Engineer to join Gore Medical on their Commercial Externally Manufactured Accessories team. This role involves ensuring product quality throughout the lifecycle of multiple products, interfacing with internal and external partners, and driving continuous improvement efforts in a high impact team for the Medical Division.
Medical DeviceHealthcareManufacturingHealth Care
No H1B
Responsibilities
Assure product quality throughout the lifecycle of multiple products by resolving quality issues, evaluating non-conforming material at our contract manufacturers, supporting the implementation of process changes at our contract manufacturers, implementing necessary product changes, and performing product surveillance activities
Partner cross-functionally, both internally and externally, to understand and evaluate fitness-for-use requirements to materials, design, processes, and test across multiple product lines
Drive changes and updates to internal design documentation, including risk documents and design control activities
Identify and monitor key product performance measures and drive continuous improvement efforts as well as propose improvements to leadership
Review internal and external documents for technical completion
Complete testing to and drive improvements to test methods
Use risk-based decision making based on deep technical and historical knowledge
Perform root cause analysis of incidents requiring corrective action
Ensure continued compliance to ISO and other global quality standards/ guidelines for product design and performance, and address documentation gaps and updates
Qualification
Required
Bachelor of Science degree in Engineering with a minimum of 3 years of hands-on engineering experience in a medical device manufacturing environment post-graduation
Experience building depth in product knowledge across the supply chain to develop or improve product specifications
Demonstrated experience applying Continuous Improvement (e.g., Lean, Six Sigma) methodologies to drive continuous improvement in a manufacturing environment, including leading structured problem-solving activities (e.g., A3, 5 Whys, Root Cause Analysis, FMEA) and delivering measurable improvements in safety, quality, cost, delivery, and productivity
Ability to make data and risk-based decisions (for example, use of statistical analysis, FMEA)
Ability to provide technical support and conduct engineering studies for multiple commercial product manufacturing lines
Demonstrated ability to manage multiple priorities, establish realistic deadlines, and drive projects to completion, while keeping stakeholders informed
Demonstrated ability to effectively interact with internal and external cross-functional teams, as well as work independently to support ongoing manufacturing
Demonstrated ability to document, communicate, and present technical bodies of work
Ability to travel domestically and internationally up to 10%
Preferred
Experience working with contract manufacturing and external suppliers
Experience in technical review of quality system documents
Benefits
Comprehensive and competitive total rewards program
Benefits that offer choice and flexibility
Associate Stock Ownership Plan
Potential opportunities for “profit-sharing”
Company
W. L. Gore & Associates
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Bret Snyder
Chair and CEO
Jack Kramer
Vice President & CTO
Recent News
BioWorld Financial Watch
2026-01-11
Venture Capital
2026-01-06
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