Quality Engineer

About the RoleWe are looking for a Quality Engineer to join our engineering team. In this role, you will utilize your skills as a member of a diverse team in providing technical support for commercialized product manufacturing. Your daily activities may include manufacturing process improvements, product quality determinations, hands-on problem solving, and ensuring operator safety.This position will be located at our facility in Flagstaff, Arizona.ResponsibilitiesDevelop 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-conformances and CAPAsEnsure 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) plansIdentify and address opportunities to continuously improve manufacturing processes and assess opportunities for regulatory, quality, ergonomic, safety, environmental, and cost impactEmploy statistical techniques to promote data driven decisions and to establish sampling plans/troubleshoot/drive continuous improvementProvide support and mentorship utilizing engineering principles and historical/materials/clinical/mechanical knowledge to ensure quality decisions are made related to product release and supplier qualityProvide technical support for the manufacturing and collaborate with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of workPromote a diverse, inclusive, and respectful team environmentRequired QualificationsBachelor’s degree in Engineering or Science with a minimum of 1 year of hands-on engineering work experience post-graduationKnowledge in Product Risk Management (Risk identification, analysis, and mitigation methods)Experience applying structured problem-solving approaches (such as 8D, 8 step, DMAIC or PDCA) that drive root cause analysis using 5-Why, Why Trees and Fishbone analysis, etcAbility to effectively document, communicate, and present technical bodies of workAbility to apply engineering fundamentals and statistical tools to develop, optimize, and troubleshoot activitiesAbility to prioritize, plan, and drive projects from development to completion against agreed upon timelines/deliverablesAbility 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 makingAbility to both work independently and collaborate effectively as part of a teamAbility to travel up to 5%Desired QualificationsExperience successfully interacting with cross-functional teams and influencing others with strong verbal and written communicationExperience in a regulated industry and with quality systems, documentation, and methodologies and adverse event reporting or post market surveillance activitiesExperience and application of Lean methodologies and approachesWhat We OfferOur 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/benefitsGore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to 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 protected 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 United States. Gore generally will not sponsor visas unless otherwise noted on the position description.