Manufacturing Quality Engineer

W. L. Gore & Associates, Inc.; Phoenix (AZ); Hybrid; USD 70,000 - 110,000; Full time

Job summary

W. L. Gore & Associates, Inc. in Phoenix, AZ is seeking an experienced Quality Engineer to support medical device manufacturing. This hands-on role focuses on quality, risk management, and process improvement across manufacturing, engineering, quality, and regulatory teams.

You will investigate nonconformances, drive corrective actions, apply statistics, and help improve yield, process capability, and safety. A hybrid remote option is available.

Qualifications

• Bachelor's degree in Engineering and 2+ years of post-graduate quality/manufacturing experience.
• Structured problem-solving approach (8D/ DMAIC/ PDCA) and root-cause tools (5 Whys, fishbone).
• Knowledge of risk-management principles and documentation.
• Apply engineering and statistics to product-quality support and process optimization.
• Identify critical issues and risk-based actions.
• Ability to manage multiple projects against timelines.
• Work independently while collaborating with cross-functional teams.
• Excellent documentation and communication of technical conclusions.
• Willingness to travel up to 5%.

Responsibilities

• Maintain quality engineering, risk-management, and design-control documentation to support product requirements and continued compliance with applicable global requirements
• Evaluate product and process nonconformances, providing risk-based recommendations for disposition and follow-up
• Lead structured problem-solving and root-cause investigations, developing and implementing effective corrective and preventive actions
• Apply engineering fundamentals, statistical analysis, and manufacturing data to support product-quality decisions and improve yield, capability, capacity, productivity, safety, and ergonomics
• Establish and improve sampling plans, visual standards, test methods, and other quality controls
• Support product and process changes, scale-up activities, test-method validation, and manufacturing validation
• Develop strong product and process knowledge to support investigations, risk assessments, change control, audits, and continuous improvement
• Collaborate with manufacturing, Quality Assurance, supply chain, regulatory, product specialists, and engineering partners to move work from problem identification through implementation
• Clearly document and communicate technical conclusions, risks, recommendations, and project status to technical and nontechnical stakeholders
• Contribute to an inclusive team environment where different perspectives are valued and used to achieve strong business and patient outcomes

Skills

Quality engineering

8D / DMAIC / PDCA

Root-cause analysis

Risk management

Statistical analysis

Engineering fundamentals

Cross-functional collaboration

Independent work

Documentation & communication

Travel up to 5%

Education

Bachelor's degree in Engineering

Job description

About the Role

We are looking for an experiencedQuality Engineer to join our team. In this hands-on role, you will provide quality engineering support for commercialized medical device manufacturing and help improve product and process performance. Your work will include investigating nonconformances, supporting product-quality decisions, improving yield and process capability, and maintaining quality and risk-management documentation. You will build deep technical knowledge while partnering across manufacturing, engineering, quality, supply chain, and regulatory to solve problems,make risk-based decisions, and drive sustainable improvements.

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

Responsibilities

• Maintain quality engineering, risk-management, and design-control documentation to support product requirements and continued compliance with applicable global requirements
• Evaluate product and process nonconformances, providing risk-based recommendations for disposition and follow-up
• Lead structured problem-solving and root-cause investigations, developing and implementing effective corrective and preventive actions
• Apply engineering fundamentals, statistical analysis, and manufacturing data to support product-quality decisions and improve yield, capability, capacity, productivity, safety, and ergonomics
• Establish and improve sampling plans, visual standards, test methods, and other quality controls
• Support product and process changes, scale-up activities, test-method validation, and manufacturing validation
• Develop strong product and process knowledge to support investigations, risk assessments, change control, audits, and continuous improvement
• Collaborate with manufacturing, Quality Assurance, supply chain, regulatory, product specialists, and engineering partners to move work from problem identification through implementation
• Clearly document and communicate technical conclusions, risks, recommendations, and project status to technical and nontechnical stakeholders
• Contribute to an inclusive team environment where different perspectives are valued and used to achieve strong business and patient outcomes

Required Qualifications

• Bachelor's degree in Engineering and a minimum of two years of relevant, post-graduate engineering experience in quality, process, product, or manufacturing engineering
• Experience applying a structured problem-solving approach, such as 8D, DMAIC, or PDCA, and root-cause analysis tools such as 5 Whys, why trees, or fishbone diagrams
• Working knowledge of product or process risk-management principles, including risk identification, analysis, mitigation, and documentation
• Ability to apply engineering fundamentals and statistical analysis to product-quality support, process optimization, and troubleshooting
• Ability to identify critical issues and failure modes, determine appropriate actions, and make sound, risk-based recommendations
• Demonstrated ability to organize and advance multiple projects or priorities against established timelines and deliverables
• Ability to work independently while building effective relationships and influencing cross-functional teams
• Ability to clearly document, communicate, and present technical work, conclusions, and recommendations
• Ability to travel up to 5%

Desired Qualifications

• Experience in the medical-device industry or another regulated manufacturing environment
• Experience leading nonconformance investigations; including product disposition, root-cause analysis, risk-based conclusions, and updates to risk-management documentation
• Experience using Lean, Six Sigma, or similar continuous-improvement methods

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.

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.