Quality Engineer

W. L. Gore & Associates; Flagstaff (AZ); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Stock Ownership Plan

Profit-sharing

Benefits package

Job summary

Gore is seeking a Quality Engineer to join its engineering team in Flagstaff, AZ. You will support product manufacturing quality, perform root cause analysis, and drive CAPAs while ensuring operator safety and regulatory compliance.

You will own quality design controls, work with QA, Manufacturing, and Regulatory, and apply structured problem-solving methods to improve processes and product release decisions. The role requires collaboration and a proactive approach.

Qualifications

• Bachelor’s degree in Engineering or Science completed.
• Experience with risk management and quality systems.
• Structured problem solving with 8D/PDCA or DMAIC approaches.
• Ability to document, communicate, and present technical work.
• Apply engineering and statistical methods to improve processes.
• Capable of planning and driving projects to completion.
• Identify critical issues and apply risk-based decisions.

Responsibilities

• Develop knowledge of product and documentation to support quality processes and CAPAs.
• Ensure ISO compliance and update design docs and risk tools.
• Own quality design control deliverables and DHF maintenance.
• Apply problem-solving techniques to root-cause non-conformances.
• Improve manufacturing processes and assess regulatory and safety impacts.
• Use statistics to support data-driven decisions and sampling plans.
• Provide mentorship and technical support to ensure quality release decisions.
• Collaborate with QA, Manufacturing, Regulatory to execute work.
• Promote a diverse, inclusive team environment.

Skills

Root cause analysis

Risk management

Statistical tools

Documentation & communication

Project planning

Independent & collaborative

Travel up to 5%

Education

Bachelor’s degree in Engineering or Science

Tools

FMEA

Job description

About The Role

We are looking for a Quality Engineer to join our engineering team. In this role, you will utilize your skills as a member of a diverse team in providing technical support for commercialized product manufacturing. Your daily activities may include manufacturing process improvements, product quality determinations, hands-on problem solving, and ensuring operator safety. This position will be located at our facility in Flagstaff, Arizona.

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 and collaborate with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of work
• Promote a diverse, inclusive, and respectful team environment

Required Qualifications

• Bachelor’s degree in Engineering or Science with a minimum of 1 year of hands-on engineering work experience post-graduation
• Knowledge in Product Risk Management (Risk identification, analysis, and mitigation methods)
• 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, etc
• Ability to effectively document, communicate, and present technical bodies of work
• Ability to apply engineering fundamentals and statistical tools to develop, optimize, and troubleshoot activities
• Ability to prioritize, plan, and drive projects from development to completion against agreed upon timelines/deliverables
• 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 both work independently and collaborate effectively as part of a team
• Ability to travel up to 5%

Desired Qualifications

• Experience successfully interacting with cross-functional teams and influencing others with strong verbal and written communication
• Experience in a regulated industry and with quality systems, documentation, and methodologies and adverse event reporting or post market surveillance activities
• Experience and application of Lean methodologies and approaches

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.