About the Role: We are seeking an experienced Quality Engineer to join our GORE VIABAHN (VSX) team. Quality Engineers are responsible for ensuring fitness for use of product designs by assessing the design’s capability to meet specification and satisfy customer needs. The role will focus on commercial manufacturing support.
This position will be located at our facility in Flagstaff, Arizona, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.
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, and address documentation gaps and updates (could include documents like FMEA, ERT, PERC etc.) Document and communicate technical plans, experimental results, and conclusions of work to satisfy quality system requirements and enable future use of knowledge 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 Maintain working knowledge of all implemented test methods, necessary test method validations, and validated test equipment, which are internally aligned and externally benchmarked Employ statistical techniques to promote data driven decisions to establish sampling plans/troubleshoot/drive continuous improvement Support technical questions from various external regulatory agencies (e.g., submission or audit follow up)Required Qualifications:
Bachelor’s degree in engineering or technical discipline with a minimum of 2 years of hands-on engineering work experience 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 Excellent communication and networking skills Ability to apply engineering fundamentals and statistical tools to development, optimization, and troubleshooting activities Ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables Ability to work independently and collaborate effectively as part of a team, including influencing across functions 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 travel up to 5%
Desired Qualifications:
Experience in a Regulated Industry
Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s hybrid working policies, from the country in which they are employed.
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
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of 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 covered 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 U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
Additional Information Travel%: 5 Shift: Day Job Schedule: Full-time Posting End Date: Feb 28, 2025