Quality Engineer: Medical Device Failure Analysis

Intellectt Inc; United States; Presencial; USD 85 000 - 130 000; Tempo integral

Resumo da oferta

Intellectt Inc is seeking a Quality Engineer with hands-on product testing, failure analysis, and laboratory investigations to support returned medical device investigations. The engineer will analyze failures, perform testing, and support root-cause investigations and CAPA within a regulated environment, collaborating across Quality, R&D, Manufacturing, and Engineering teams.

This 12+ month role emphasizes documentation, test protocol development, and continuous improvement of

Qualificações

• 4+ years in Quality Engineering or related field.
• Experience with product failure investigations.
• Lab testing, troubleshooting, and evaluation experience.
• Knowledge of CAPA, NCR/nonconformance and quality processes.
• Experience in medical devices is preferred.

Responsabilidades

• Conduct failure investigations on returned medical products and identify potential failure modes.
• Perform hands-on laboratory testing and product evaluation to reproduce and understand failures.
• Analyze test results, product performance, and failure data to determine potential root causes.
• Support root cause analysis, CAPA, nonconformance, and quality investigations.
• Develop and execute test methods/protocols to evaluate product failures and performance.
• Document investigation findings, test results, and technical conclusions in accordance with quality procedures.
• Collaborate with Quality, R&D, Manufacturing, and Engineering teams to resolve product quality issues.
• Support continuous improvement and implementation of corrective/preventive actions.

Conhecimentos

Quality engineering

Failure analysis

Laboratory testing

Root cause analysis

CAPA

Documentation

Cross-functional collab

Descrição da oferta de emprego

Intellectt Inc is seeking a Quality Engineer with hands-on product testing, failure analysis, and laboratory investigations to support returned medical device investigations. The engineer will analyze failures, perform testing, and support root-cause investigations and CAPA within a regulated environment, collaborating across Quality, R&D, Manufacturing, and Engineering teams.

This 12+ month role emphasizes documentation, test protocol development, and continuous improvement of