About the Role
We are looking for an experienced Quality Engineer to join our team. In this role, you will utilize your skills as a member of a diverse team in providing technical support of commercialized product manufacturing. Your daily activities may include manufacturing process improvements, product quality determinations, hands-on problem solving, and ensuring operator safety. You will be a part of installation, operation, maintenance and upgrade of production equipment and workflow.
Diversity is a core value at Gore. We are passionate about building and sustaining an inclusive and equitable work environment for all Associates. We believe every member of our team enriches our work environment by exposing us to a broad range of perspectives to understand and engage with our customers, suppliers, and each other.
This role will be located at our facility in Flagstaff, Arizona.
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 (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) plans
- Identify and address opportunities to continuously improve our manufacturing processes and assess opportunities for regulatory, quality, ergonomic, safety, environmental, and cost impact
- Employ statistical techniques to promote data driven decisions to establish sampling plans/troubleshoot/drive continuous improvement
- Partner with other engineers in a wide range of process projects throughout the development cycles: scale-up, validation, and improvement (improved safety, cost, quality, capability, and capacity)
- 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
- Provide technical support for the manufacturing of the GORE® CARDIOFORM Septal Occluder and CARDIOFORM ASD Occluder and collaborate with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of work
- Practice equitable and inclusive behaviors with other Associates to achieve outstanding results
Required Qualifications
- Bachelor’s Degree in Engineering with minimum 3 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
- Knowledge in Product Risk Management (Risk identification, analysis, and mitigation methods)
- Ability to apply engineering fundamentals and statistical analysis to product quality support, 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 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 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 document, communicate, and present technical bodies of work
- Ability to travel up to 5%
Desired Qualifications
- Direct experience in a quality, process, product or manufacturing engineering role post-graduation
- Experience in a Regulated Industry
- Experience with quality systems, documentation, and methodologies (for example, GMP, ISO 9001, APQP, House of Quality, etc)
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
Gore 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.
