Senior Design Quality Engineer

Overview

BrioHealth Solutions is a global team of Med-Tech professionals focused on patient-centric solutions in a collaborative environment. We have developed the BrioVAD Left Ventricular Assist System (LVAS) for chronic mechanical circulatory support. We are initiating the INNOVATE Trial in the US and are building a team to develop advanced technology to improve patient outcomes and increase therapy access globally.

Job Summary

Returned Product Analysis (RPA) Quality Engineer to drive quality assurance compliance for implantable medical devices, supporting clinical and commercial operations. Lead complaint handling, root cause analysis, FDA reporting, and returned product investigations to ensure continuous improvement in product safety and performance. This is a high-impact role contributing to product quality, failure analysis processes, and regulatory compliance.

Responsibilities

• Lead device history reviews, returned product evaluations, and failure investigations to determine root causes.
• Conduct visual and functional inspections of returned devices and peripherals.
• Collaborate with engineering, manufacturing, and R&D teams to identify and implement corrective actions.
• Develop and refine inspection, testing, and evaluation methodologies for returned products.
• Author comprehensive technical reports documenting findings, root causes, and CAPA recommendations.

Regulatory Compliance & Reporting

Quality Management & Continuous Improvement

Additional Responsibilities

Qualifications

Additional Details

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