Senior Quality Assurance Engineer — MedTech (Design to Manufacturing)

Confluent Medical; Austin (TX); On-site; USD 90,000 - 135,000; Full time

Job summary

Confluent Medical Technologies is seeking a Quality Assurance Engineer to join our Austin, TX team. The role focuses on ensuring compliance with customer, risk management, quality and design controls, and assisting in the transfer of designs to manufacturing.

You will participate in design reviews, risk assessments, CAPA investigations and audit support, leveraging statistical analysis and Minitab to maintain robust quality systems in a medical device environment.

Qualifications

• BS in a related engineering discipline; and 5 years of related experience in quality for medical devices.
• MS in a related engineering discipline and 3 years of related experience in quality in a medical device environment (optional).

Responsibilities

• Ensure compliance with customer, risk management, quality and design control requirements.
• Support transfer of design to manufacturing.
• Coordinate design reviews and risk analyses.
• Assist in investigations of CAPAs and non-conformances.
• Prepare documentation for internal and external audits.

Skills

Statistical data analysis

Quality systems

Regulatory knowledge

Problem solving

Education

BS in engineering

MS in engineering

Tools

Minitab

Microsoft Office

Job description

Confluent Medical Technologies is seeking a Quality Assurance Engineer to join our Austin, TX team. The role focuses on ensuring compliance with customer, risk management, quality and design controls, and assisting in the transfer of designs to manufacturing.

You will participate in design reviews, risk assessments, CAPA investigations and audit support, leveraging statistical analysis and Minitab to maintain robust quality systems in a medical device environment.