Quality Engineer

wlgore; Phoenix (AZ); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Gore seeks an experienced Quality Engineer in Phoenix, Arizona, to support the manufacturing of implantable devices and maintain ISO compliance. You will update quality system documentation, perform product quality determinations, and work with cross-functional teams to ensure regulatory and quality standards are met.

Responsibilities include CAPA, design history file ownership, and collaboration with QA, Manufacturing, and Regulatory to drive root-cause analyses and continuous improvement.

Qualifications

• Bachelor’s degree in engineering or science with minimum 3 years of hands-on engineering experience.

Responsibilities

• Ensure continued compliance to ISO and global quality standards/guidelines for product design and performance; address documentation gaps and updates (FMEAs, ERT, PERC).
• Identify and address opportunities to improve manufacturing processes and assess regulatory, quality, ergonomic, safety, environmental, and cost impact.
• Employ statistical techniques to promote data-driven decisions; establish sampling plans and troubleshoot for continuous improvement.
• Partner with engineers across development cycles: scale-up, validation, and improvement.
• Provide support and mentorship using engineering principles to ensure quality decisions for product release and supplier quality.
• Provide technical support for manufacturing Gore PRECLUDE Pericardial Membrane and GORE-TEX Cardiovascular Patch; collaborate with QA, Manufacturing, Regulatory.
• Apply formal problem-solving to determine root cause in CAPA and implement corrective actions.
• Own design control deliverables and maintain Design History Files (input/output docs, risk tools).
• Develop deep technical knowledge of product documentation to support audits and change control.

Skills

Structured problem-solving

Root cause analysis

Statistical analysis

Project management

Cross-functional collaboration

Documentation and communication

Travel up to 5%

Education

Bachelor’s Degree in Engineering or Science

Job description

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 updating quality system documentation, aiding in product quality determinations, hands‑on problem solving, and ensuring operator safety. You will be a part of cross‑functional teams that ensure continued compliance with ISO and other global quality standards/guidelines that are applicable to implantable medical devices.

This role will be located at one of our facilities in Phoenix, Arizona with the possibility of a hybrid work arrangement.

Responsibilities

• Practice equitable and inclusive behaviors with other Associates to achieve outstanding results
• 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)
• 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® PRECLUDE Pericardial Membrane and GORE‑TEX® Cardiovascular Patch in addition to collaborating with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of work
• Apply formal problem-solving techniques to determine root cause in troubleshooting product non‑conformances and developing and implementing corrective and preventative action (CAPA) plans
• 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)
• 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

Required Qualifications

• Bachelor’s Degree in Engineering or Science 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

• Minimum 3 years of relevant engineering experience in the Medical Device Industry
• Experience with applicable regulatory standards and quality system expectations (e.g., FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971)

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.

About Gore

For over 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what’s possible — not just through our products and technologies but also through individual growth and development.

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. Our Associates build on a rich history of innovation, upholding Gore’s values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.