Quality Engineer, Medical Devices (Hybrid)

Sitka Inc.; Flagstaff (AZ); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work arrangement

Associate Stock Ownership Plan

Profit-sharing opportunities

Job summary

Gore is seeking a Quality Engineer to join our team in Flagstaff, Arizona. In this hands-on role, you will provide quality engineering support for commercialized medical device manufacturing, investigate nonconformances, support product-quality decisions, and drive process improvements.

You will collaborate across manufacturing, engineering, quality, supply chain, and regulatory to solve problems and ensure compliance with global requirements.

Qualifications

• Bachelor’s degree in Engineering or Science with 5+ years in quality, process, product, or manufacturing engineering.
• Experience applying structured problem-solving methods (8D, DMAIC, PDCA) and root-cause tools (5 Whys, fishbone).
• Knowledge of risk-management principles, including analysis, mitigation, and documentation.
• Ability to apply engineering fundamentals and statistics to quality support and process optimization.
• Ability to identify critical issues, make risk-based decisions, and manage multiple priorities.

Responsibilities

• Maintain quality and risk-management documentation to support product requirements and compliance.
• Evaluate nonconformances and provide risk-based disposition recommendations.
• Lead root-cause investigations and implement corrective actions.
• Apply statistical analysis and manufacturing data to improve yield, capability, and productivity.
• Establish sampling plans, visual standards, and test methods.
• Support changes, scale-up, validation, and manufacturing validation.
• Develop product/process knowledge for investigations, risk assessments, and audits.
• Collaborate across manufacturing, QA, supply chain, regulatory, and engineering partners.
• Document and communicate conclusions, risks, and project status to stakeholders.
• Contribute to an inclusive team environment and patient outcomes.

Skills

Structured problem-solving

Root-cause analysis

Risk-management principles

Engineering fundamentals & statistics

Cross-functional collaboration

Travel up to 5%

Education

Bachelor’s degree in Engineering or Science

Tools

Lean

Six Sigma

Job description

Gore is seeking a Quality Engineer to join our team in Flagstaff, Arizona. In this hands-on role, you will provide quality engineering support for commercialized medical device manufacturing, investigate nonconformances, support product-quality decisions, and drive process improvements.

You will collaborate across manufacturing, engineering, quality, supply chain, and regulatory to solve problems and ensure compliance with global requirements.