Quality Engineer (Manufacturing)

W. L. Gore & Associates, Inc.; Flagstaff (AZ); On-site; USD 70,000 - 95,000; Full time

Job summary

W. L. Gore & Associates, Inc.

is seeking an experienced Quality Engineer to join our Flagstaff, Arizona team. You will support commercialized product manufacturing, drive process improvements, perform quality determinations, and participate in installation, operation, maintenance and upgrade of production equipment and workflow. The role emphasizes hands-on problem solving, design history file maintenance, and compliance with ISO and global quality standards.

Qualifications

• Requires bachelor's degree in engineering and 1+ year in manufacturing support.
• Proficient in structured problem-solving methods (8D/8-Step/DMAIC/PDCA).
• Knowledge of Product Risk Management and risk mitigation.

Responsibilities

• Develop deep technical knowledge of product and documentation to support quality processes and CAPAs.
• Ensure compliance to ISO and global quality standards for design and performance.
• Own quality engineering design control deliverables and maintain Design History Files.
• Apply formal problem-solving to identify root causes of non-conformances and implement CAPAs.
• Identify opportunities to improve manufacturing processes and assess regulatory, safety, and cost impacts.
• Use statistical techniques to drive data-driven decisions and sampling plans.
• Collaborate with engineers on scale-up, validation, and improvement projects.
• Provide technical support for manufacturing of GORE CARDIOFORM devices.
• Support manufacturing, regulatory, and quality assurance in execution of work.
• Promote equitable and inclusive behaviors within the team.

Skills

Structured problem-solving (8D/DMAIC/5

Education

Bachelor's degree in Engineering

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
• 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 a minimum of 1 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 2 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