Job: Engineers, Scientists & Tech
Primary Location: Americas-US-AZ-Flagstaff
Travel%: 10%
Shift: Day
Schedule: Full-time
Quality Engineer-231114
About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries
About the Role: Are you a Quality Engineer looking for a collaborative work environment where your unique contributions will help ensure our innovative products that improve life perform as promised, time and time again? We are looking for Quality Engineers to join various teams in our Medical Products Division and Core Technology Division in Flagstaff, Arizona. As a Quality Engineer at Gore, you can contribute to many areas of a product’s lifecycle, which may include Manufacturing, Product Development or a Technology Platform.
This position will be located at our facilities in Flagstaff, Arizona, with work from home days possible as part of a hybrid 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, addressing 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
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)
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
Required Qualifications:
Bachelor’s Degree in Engineering with at least 3 years of hands-on engineering work experience
Ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
Knowledge in product risk management (risk identification, analysis, and mitigation methods)
Ability to apply engineering fundamentals and statistical analysis to product quality support, trending, improvement, and troubleshooting
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
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 document, communicate, and present technical bodies of work
Ability to travel up to 10%
Desired Qualifications:
Experience in a regulated industry
Experience coaching or mentoring
Experience with quality systems, documentation, and methodologies (for example, GMP, ISO 9001, APQP, House of Quality, etc)
- Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. Locations not eligible for new remote work arrangements include: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
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.
Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.)
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
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