Quality Engineer

Intellectt Inc; United States; On-site; USD 85,000 - 130,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality engineering

Failure analysis

Laboratory testing

Root cause analysis

CAPA

Documentation

Cross-functional collab

Job description

Duration: 12+ months, with possibility of extension/conversion

Job Summary

We are seeking a Quality Engineer with hands-on experience in product testing, failure analysis, and laboratory investigations to support returned medical device/product investigations. The engineer will analyze product failures, identify failure modes, perform testing, and support root cause investigations and corrective actions.

Key Responsibilities

• 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.

Required Qualifications

• 4+ years of Quality Engineering, Product Testing, Failure Analysis, or Laboratory Engineering experience.
• Hands-on experience with product failure investigations and failure mode analysis.
• Laboratory experience performing testing, troubleshooting, and product evaluation.
• Knowledge of root cause analysis, CAPA, NCR/nonconformance, and quality processes.
• Strong technical documentation and problem-solving skills.
• Medical device or other regulated-industry experience preferred.