Quality Engineer

W. L. Gore & Associates; Arizona; Hybrid; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

W. L. Gore & Associates is seeking a Quality Engineer to provide hands-on quality engineering support for medical device manufacturing.

You will investigate nonconformances, improve yield and process capability, and maintain quality and risk-management documentation, collaborating across manufacturing, engineering, quality, supply chain, and regulatory to drive sustainable improvements. This position is located at our Flagstaff, Arizona facility with a hybrid work arrangement.

Qualifikationen

• Bachelor’s degree in Engineering or Science required.
• 5+ years post-graduate engineering or quality/manufacturing experience.
• Structured problem-solving methods (8D, DMAIC, PDCA) required.
• Knowledge of risk-management principles and documentation.
• Ability to apply statistics to product-quality support and process optimization.
• Ability to identify failure modes and risk-based actions.
• Ability to manage multiple projects with deadlines.
• Ability to work independently and influence cross-functional teams.
• Willingness to travel up to 5%.

Aufgaben

• Maintain quality documentation to support product requirements and compliance.
• Evaluate nonconformances and provide risk-based disposition.
• Lead root-cause investigations and implement CAPAs.
• Apply statistics to improve yield and process capability.
• Develop sampling plans, test methods, and quality controls.
• Support changes, scale-up, and validation activities.
• Collaborate across functions to move work from problem to solution.
• Communicate technical conclusions to stakeholders.
• Contribute to an inclusive, high-performing team.
• Travel up to 5%.

Kenntnisse

Structured problem-solving

Root-cause analysis

Statistical analysis

Cross-functional collaboration

Project management

Communication

Independent work

Documentation

Ausbildung

Bachelor’s degree in Engineering or Science

Tools

8D/ DMAIC/ PDCA

5 Whys / Fishbone

Jobbeschreibung

About The Role

We are looking for a Quality 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.

About The Role

We are looking for a Quality 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 our facility in Flagstaff, Arizona, with the possibility of a hybrid 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 or Science and minimum of 5 years post-graduate engineering or relevant 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.
• 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.