Manufacturing Quality Engineer - Process Improvement

W. L. Gore & Associates; Arizona; On-site; USD 75,000 - 105,000; Full time

Job summary

W. L. Gore & Associates in Flagstaff, Arizona is seeking an experienced Quality Engineer to support commercialized product manufacturing.

You will participate in process improvements, product quality determinations, problem solving, and ensure operator safety as part of installation, operation, maintenance and upgrade of production equipment and workflow. Responsibilities include root-cause analysis of non-conformances, CAPAs, maintaining Design History Files, applying statistical methods, and

Qualifications

• 3+ years of experience in a manufacturing environment
• Experience applying structured problem-solving approaches (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%

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

Skills

Problem solving

Statistical analysis

Team collaboration

Technical communication

Hands-on manufacturing

Education

Bachelor's degree in Engineering

Job description

W. L. Gore & Associates in Flagstaff, Arizona is seeking an experienced Quality Engineer to support commercialized product manufacturing.

You will participate in process improvements, product quality determinations, problem solving, and ensure operator safety as part of installation, operation, maintenance and upgrade of production equipment and workflow. Responsibilities include root-cause analysis of non-conformances, CAPAs, maintaining Design History Files, applying statistical methods, and