Quality Engineer - Manufacturing & Process Improvement

Sitka Inc.; Flagstaff (AZ); On-site; USD 85,000 - 125,000; Full time

Job summary

Gore in Flagstaff, AZ seeks an experienced Quality Engineer to support manufacturing quality for complex devices, including audits, CAPA, and risk management. You will work hands-on in a hybrid facility, driving root cause analysis and implementing corrective actions while ensuring operator safety and regulatory compliance.

You will collaborate with cross-functional teams to maintain Design History Files and ensure product quality throughout design, development, and production, with emphasis on

Qualifications

• Bachelor’s degree in Engineering and minimum of 3 years of experience in a manufacturing setting.
• Structured problem-solving approaches (8D, DMAIC, PDCA) and root cause analysis.
• Knowledge of Product Risk Management and regulatory quality standards.
• Ability to apply engineering fundamentals and statistical analysis to quality support.

Responsibilities

• Develop deep product knowledge to support quality processes (audit, change control) and drive root-cause analysis for non-conformances.
• Ensure compliance with ISO standards and other global quality guidelines for design and performance.
• Own quality design control deliverables and maintain Design History Files.
• Apply problem-solving techniques to develop CAPA plans and drive improvements.
• Identify opportunities to improve manufacturing processes and assess regulatory and cost impacts.
• Use statistical methods to drive data-driven decisions and sampling plans.

Skills

Structured problem solving

Risk management

Statistical analysis

Engineering fundamentals

Team collaboration

Strong communication

Education

Bachelor’s degree in Engineering

Job description

Gore in Flagstaff, AZ seeks an experienced Quality Engineer to support manufacturing quality for complex devices, including audits, CAPA, and risk management. You will work hands-on in a hybrid facility, driving root cause analysis and implementing corrective actions while ensuring operator safety and regulatory compliance.

You will collaborate with cross-functional teams to maintain Design History Files and ensure product quality throughout design, development, and production, with emphasis on