MedTech Quality Assurance Engineer – Design Controls

CONFLUENT MEDICAL TECHNOLOGIES INC.; Austin (TX); On-site; USD 85,000 - 125,000; Full time

Job summary

Confluent Medical Technologies Inc. in Austin, TX is seeking a Quality Assurance Engineer to ensure compliance with customer, risk management, quality and design control requirements across design and development projects.

You will support transfer of designs to manufacturing, conduct design reviews, perform statistical analyses with Minitab, and manage CAPAs, SCARs and external audits while upholding ISO 13485 and FDA requirements.

Qualifications

• BS degree in engineering; 5+ years in quality in medical devices; or MS with 3+ years in quality
• Experience with FDA, ISO 13485 and EU MDR design control requirements
• Strong knowledge of ISO 14971 and IEC 62366

Responsibilities

• Develop, apply, revise, and maintain quality and regulatory standards for medical devices.
• Inspect, test, and evaluate products and production equipment.
• Lead design reviews and pre-validation assessments to ensure the safe startup of new processes.
• Generate and maintain risk management files (FMEAs, risk reports, hazard analyses).
• Provide guidance on statistics, DOE, process capability analysis, and ANOVA.
• Prepare Process Validation Protocols and Reports.
• Coordinate with customers and Notified Bodies during audits.
• Investigate and manage customer field complaints, SCARs and CAPAs.

Skills

Statistical analysis

Quality Assurance

Regulatory compliance

Design controls

Risk management

Minitab

Microsoft Office

Education

Bachelor's degree in Engineering

Master of Science in Engineering

Tools

Minitab

Microsoft Office

Job description

Confluent Medical Technologies Inc. in Austin, TX is seeking a Quality Assurance Engineer to ensure compliance with customer, risk management, quality and design control requirements across design and development projects.

You will support transfer of designs to manufacturing, conduct design reviews, perform statistical analyses with Minitab, and manage CAPAs, SCARs and external audits while upholding ISO 13485 and FDA requirements.