Quality Engineer - Multiple Opportunities
Job description
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 in Flagstaff, AZ and Core Technology Division in Flagstaff, AZ. 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.*
- 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).
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
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