Quality Engineer - Medical Device Manufacturing

Sitka Inc.; Flagstaff (AZ); Presencial; USD 75 000 - 105 000; Tempo integral

Resumo da oferta

Gore is seeking an experienced Quality Engineer to support medical device manufacturing at our Flagstaff, Arizona facility. The role focuses on process improvements, product quality determinations, problem solving, and ensuring operator safety while contributing to installation, operation, maintenance and upgrade of production equipment and workflow.

You will apply formal problem-solving techniques to drive root-cause analysis, maintain Design History Files, and collaborate across Quality,

Qualificações

• Bachelor’s degree in Engineering (or equivalent) with relevant manufacturing exposure.
• Experience applying 8D/PDCA/ DMAIC/Why-Why analysis for root-cause investigation.
• Knowledge of Product Risk Management and failure mode awareness.

Responsabilidades

• Develop deep product/process knowledge to support quality controls and CAPA activities.
• Maintain conformity to ISO and global quality guidelines for design and performance; address documentation gaps.
• Own quality design controls and DHF content, including risk management tools.

Conhecimentos

Structured problem solving

Statistical analysis

Quality systems

Engineering fundamentals

Project management

Technical communication

Team collaboration

Formação académica

Bachelor’s degree in Engineering

Descrição da oferta de emprego

Gore is seeking an experienced Quality Engineer to support medical device manufacturing at our Flagstaff, Arizona facility. The role focuses on process improvements, product quality determinations, problem solving, and ensuring operator safety while contributing to installation, operation, maintenance and upgrade of production equipment and workflow.

You will apply formal problem-solving techniques to drive root-cause analysis, maintain Design History Files, and collaborate across Quality,