Quality Engineer, Medical Devices (Hybrid)

Sitka Inc.; Phoenix (AZ); Hybrid; USD 75,000 - 110,000; Full time

Job summary

Gore in Phoenix, AZ seeks an experienced Quality Engineer to support medical device manufacturing. This hands-on role focuses on nonconformance investigation, risk-based decisions, yield and process capability improvements, and robust quality documentation. Hybrid work arrangement; travel up to 5% may be required.

You will collaborate with manufacturing, quality, supply chain, regulatory, and engineering to drive sustainable improvements and ensure compliance with global requirements.

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%

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

Structured problem solving

Risk management

Statistical analysis

Cross-functional collaboration

Documentation

Education

Bachelor’s degree in Engineering

Job description

Gore in Phoenix, AZ seeks an experienced Quality Engineer to support medical device manufacturing. This hands-on role focuses on nonconformance investigation, risk-based decisions, yield and process capability improvements, and robust quality documentation. Hybrid work arrangement; travel up to 5% may be required.

You will collaborate with manufacturing, quality, supply chain, regulatory, and engineering to drive sustainable improvements and ensure compliance with global requirements.