About the Role

We are looking for an experienced Quality Engineer to join Gore Medical on our Commercial Externally Manufactured Accessories team.  This individual will have repeatedly demonstrated their skill in applying critical thinking to solve technical manufacturing challenges within quality documentation and successfully navigating ambiguity to breakdown problems to identify and define solutions with competing priorities.  In this role, your daily activities will include interfacing with internal and external partners and evaluating fitness-for-use across the entire lifecycle of externally manufactured devices. You will be crucial in ensuring the quality and longevity of our existing products in a high impact team to the Medical Division. As a Quality Engineer, your daily activities may include evaluation of complaint devices, testing product to specifications, driving clarity to specifications, keeping design documentation up to date, and implementing corrective actions while ensuring relationships with cross-functional partners are intact.  

This position will be located at our facility in Flagstaff, Arizona.

Responsibilities

• Assure product quality throughout the lifecycle of multiple products by resolving quality issues, evaluating non-conforming material at our contract manufacturers, supporting the implementation of process changes at our contract manufacturers, implementing necessary product changes, and performing product surveillance activities
• Partner cross-functionally, both internally and externally, to understand and evaluate fitness-for-use requirements to materials, design, processes, and test across multiple product lines
• Drive changes and updates to internal design documentation, including risk documents and design control activities
• Identify and monitor key product performance measures and drive continuous improvement efforts as well as propose improvements to leadership
• Review internal and external documents for technical completion
• Complete testing to and drive improvements to test methods
• Use risk-based decision making based on deep technical and historical knowledge
• Perform root cause analysis of incidents requiring corrective action
• Ensure continued compliance to ISO and other global quality standards/ guidelines for product design and performance, and address documentation gaps and updates

Required Qualifications

• Bachelor of Science degree in Engineering with a minimum of 3 years of hands-on engineering experience in a medical device manufacturing environment post-graduation
• Experience building depth in product knowledge across the supply chain to develop or improve product specifcations
• Demonstrated experience applying Continuous Improvement (e.g., Lean, Six Sigma) methodologies to drive continuous improvement in a manufacturing environment, including leading structured problem-solving activities (e.g., A3, 5 Whys, Root Cause Analysis, FMEA) and delivering measurable improvements in safety, quality, cost, delivery, and productivity
• Ability to make data and risk-based decisions (for example, use of statistical analysis, FMEA)
• Ability to provide technical support and conduct engineering studies for multiple commerical product manufacturing lines
• Demonstrated ability to manage multiple priorities, establish realistic deadlines, and drive projects to completion, while keeping stakeholders informed
• Demonstrated ability to effectively interact with internal and external cross-functional teams, as well as work independently to support ongoing manufacturing
• Demonstrated ability to document, communicate, and present technical bodies of work
• Ability to travel domestically and internationally up to 10%

Desired Qualifications

• Experience working with contract manufacturing and external suppliers
• Experience in technical review of quality system documents