Quality Engineer (Manufacturing)

W. L. Gore & Associates, Inc.; Phoenix (AZ); On-site; USD 85,000 - 120,000; Full time

Job summary

W. L. Gore & Associates, Inc. in Flagstaff, Arizona, is seeking an experienced Quality Engineer to support manufacturing, drive process improvements, and solve problems hands‑on while ensuring operator safety and quality.

The role involves owning quality design controls, maintaining Design History Files, applying CAPA methods, and collaborating with cross‑functional teams to meet ISO and global quality standards.

Qualifications

• Bachelor's degree in Engineering and minimum of 3 years of experience in manufacturing.
• Experience applying structured problem-solving approaches (8D/PDCA/DMAIC) to root-cause analysis.
• Knowledge in Product Risk Management and mitigation methods.
• Apply engineering fundamentals and statistical analysis to quality support and troubleshooting.
• Ability to manage multiple projects with timelines and commitments.
• Strong collaboration, mentoring abilities, and independent prioritization.
• Identify critical issues and perform risk-based decision making.
• Strong technical communication for documenting and presenting work.
• Willingness to work in a hands-on manufacturing environment.
• Ability to travel up to ~5%.

Responsibilities

• Develop deep knowledge of product documentation to support quality processes and root-cause discovery.
• Ensure ISO and global quality standards compliance and update documentation (FMEAs, ERT, PERC).
• Own quality design control deliverables and maintain Design History Files.
• Apply problem-solving techniques to non-conformances and implement CAPA plans.
• Identify opportunities to improve manufacturing processes and assess regulatory and safety impacts.
• Use statistics to guide sampling plans and continuous improvement.
• Collaborate with engineers across development cycles (scale-up, validation, improvement).
• Provide mentorship to ensure quality decisions on product release and supplier quality.
• Support manufacturing of Gore CARDIOFORM devices and coordinate with Quality.
• Coordinate with Assurance, Manufacturing, and Regulatory; promote inclusive behavior.

Skills

Structured problem-solving

Statistical analysis

Technical communication

Team collaboration

Mentoring

Education

Bachelor's degree in Engineering

Tools

FMEA

ERT

PERC

Job description

About the Role

We are looking for an experienced Quality Engineer to join our team. In this role, you will utilize your skills as a member of a diverse team in providing technical support of commercialized product manufacturing. Your daily activities may include manufacturing process improvements, product quality determinations, hands‑on problem solving, and ensuring operator safety. You will be a part of installation, operation, maintenance and upgrade of production equipment and workflow.

This role is 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‑conformance 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 our manufacturing processes and assess opportunities for regulatory, quality, ergonomic, safety, environmental, and cost impact
• Employ statistical techniques to promote data driven decisions to establish sampling plans/troubleshoot/drive continuous improvement
• Partner with other engineers in a wide range of process projects throughout the development cycles: scale‑up, validation, and improvement (improved safety, cost, quality, capability, and capacity)
• 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 CARDIOFORM Septal Occluder and CARDIOFORM ASD Occluder and collaborate with other functions such as Quality
• Assurance, Manufacturing, and Regulatory in execution of work
• Practice equitable and inclusive behaviors with other Associates to achieve outstanding results

Required Qualifications

• Bachelor's degree in Engineering and minimum of 3 years of experience supporting a manufacturing environment
• Experience applying structured problem‑solving approach (such as 8D, 8-Step, DMAIC or PDCA) that drives 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 and manage multiple projects concurrently, delivering results against timelines and commitments.
• 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
• 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
• Strong technical communication skills, including documenting and presenting technical work
• Willingness to work in a hands‑on manufacturing environment
• Ability to travel up to ~5%

Desired Qualifications

• Minimum 5 years of experience in a regulated manufacturing environment (e.g., medical device, pharmaceutical, aerospace, or similar)
• Experience with quality systems, documentation, and methodologies (for example, MP, ISO 9001, APQP, House of Quality, etc)
• Applied experience using Lean, Six Sigma, Problem‑solving, or other similar methodologies for process improvement and root cause analysis