Medical Device QA Engineer: Design-to-Production Innovator

Confluent Medical Technologies INC; Austin (TX); On-site; USD 95,000 - 125,000; Full time

Job summary

Confluent Medical Technologies INC seeks a Quality Assurance Engineer in Austin, TX to ensure compliance with FDA, ISO 13485, and EU MDR. You will lead risk management activities, participate in design reviews, and support transfer to manufacturing while maintaining QA systems.

You will develop and execute validation and verification plans, analyze data with Minitab, and interact with customers and suppliers to resolve quality issues.

Qualifications

• BS in a related engineering discipline and 5 years in medical device quality.
• MS in engineering and 3 years in medical device quality.
• 3+ years in medical device product development and FDA/ISO knowledge.

Responsibilities

• Develop and maintain quality systems and procedures to ensure compliance with FDA, ISO 13485, and EU MDR.
• Lead risk management activities including FMEAs and risk control processes.
• Support design reviews, process validation plans and verification testing.

Skills

Quality Assurance

Statistical analysis

Regulatory compliance

Design reviews

Education

BS in engineering

MS in engineering

Tools

Minitab

Excel

Document control systems

Job description

Confluent Medical Technologies INC seeks a Quality Assurance Engineer in Austin, TX to ensure compliance with FDA, ISO 13485, and EU MDR. You will lead risk management activities, participate in design reviews, and support transfer to manufacturing while maintaining QA systems.

You will develop and execute validation and verification plans, analyze data with Minitab, and interact with customers and suppliers to resolve quality issues.