W. L. Gore & Associates · 5 hours ago
Quality Engineer
Flagstaff, AZ
Full-time
Onsite
Entry, Mid Level
2+ years expW. L. Gore & Associates is seeking an experienced Quality Engineer to join their Viabahn Self Expanding engineering team. The role involves providing technical support for commercialized product manufacturing, focusing on quality processes, manufacturing improvements, and ensuring compliance with global quality standards.
Health CareManufacturingMedical Device
No H1B
Responsibilities
Develop deep technical and historical knowledge of the product/product documentation to support quality processes (audit, change control) and drive the discovery of root causes in non-conformances and CAPAs
Ensure continued compliance to ISO and other global quality standards/guidelines for product design and performance, addressing documentation gaps and updates (including documents such as FMEAs, ERT, PERC, etc.)
Ensure design requirements are met by owning quality engineering design control deliverables and maintaining product Design History Files (i.e., Design input/output documentation, Risk management tools)
Apply formal problem-solving techniques to determine root cause in troubleshooting product non-conformances and developing and implementing corrective and preventative action (CAPA) plans
Identify and address opportunities to continuously improve manufacturing processes and assess opportunities for regulatory, quality, ergonomic, safety, environmental, and cost impact
Employ statistical techniques to promote data driven decisions and to establish sampling plans/troubleshoot/drive continuous improvement
Provide support and mentorship utilizing engineering principles and historical/materials/clinical/mechanical knowledge to ensure quality decisions are made related to product release and supplier quality
Provide technical support for the manufacturing of the GORE® VIABAHN ® Endoprosthesis and collaborate with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of work
Promote a diverse, inclusive, and respectful team environment
Qualification
Required
Bachelor's degree in engineering with minimum 2 years of hands-on experience in an engineering position supporting a manufacturing organization
Experience applying structured problem-solving approaches (such as 8D, 8-Step, DMAIC or PDCA) that drive root cause analysis using 5-Why, Why Trees, and Fishbone analysis
Knowledge in Product Risk Management (Risk identification, analysis, and mitigation methods)
Ability to apply engineering fundamentals and statistical analysis to product quality support, optimization, and troubleshooting activities
Ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
Ability to work effectively in team situations, building an inclusive environment, mentoring others, as well as the ability to independently prioritize, initiate, and drive projects to completion as part of a team
Ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk-based decision making
Ability to document, communicate, and present technical bodies of work
Ability to travel up to 5%
Preferred
Direct experience in a quality, process, product, or manufacturing engineering role post-graduation
Experience in a Regulated Industry
Experience with quality systems, documentation, and methodologies (for example, GMP, ISO 9001, APQP, House of Quality, etc.)
Benefits
Comprehensive and competitive total rewards program
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
Company data provided by crunchbase