Returned Product Analysis Sr. Quality Engineer

Sr. Quality Engineer – Returned Product Analysis

Job DescriptionBrioHealth Solutions Inc., Inc. is seeking a Returned Product AnalysisQuality Engineer to support QA compliance activities for an active implantable medical device, covering both clinical and commercial needs. In this role, you'll oversee and lead all facets of complaint handling, FDA reporting, analyzing returned implantable medical devices and their external peripherals, and for providing input to continuous improvement efforts. Analyze returned devices and peripherals, identify root causes, and contribute to quality and safety enhancements.Responsibilities

Complaint Investigation and Product Analysis:

• Lead device history reviews, Returned Product evaluations, and quality characteristic analysis for customer returns.
• Compile complaint data and report findings to relevant teams.
• Conduct and support failure investigations to identify root causes.
• Propose improvements to inspection, testing, and evaluation methods for complaint-related products.
• Analyze design, reliability, and yield issues to determine root cause of failures.
• Collaborate with cross-functional teams (engineering, manufacturing, R&D) to investigate issues and identify corrective actions.
• Author technical reports documenting findings, root causes, and recommendations for prevention and CAPA actions.

Regulatory Compliance and Reporting:

• Ensure compliance with QSR, global regulations, and complaint investigation requirements.
• Support complaint investigation process during audits/inspections.
• Possess a knowledge of Occupational Safety and Health Administration (OSHA) or the Centers for Disease Control and Prevention (CDC) regulations regarding the handling of potentially biohazardous materials.

Quality Management and Continuous Improvement:

• Initiate and support continuous improvement initiatives for complaints and overall business.
• Participate in assigned projects (e.g., metrics, change requests, SOP updates).
• Collaborate with key quality and business partners to ensure full investigation of product quality issues.
• Contribute to the development and implementation of CAPA plans.
• Stay current on relevant regulatory requirements and industry standards.
• Contribute to the continuous improvement of the Returned Product Analysis process.

Additional Responsibilities:

• Receive, document, and log returned devices and peripherals.
• Conduct visual and functional inspections of returned devices.
• Perform failure analysis investigations using relevant techniques.
• Prepare detailed reports documenting the analysis process, findings, and recommendations.

Requirements

• Bachelor’s degree in engineering, science, or a related field.
• Minimum of 2 years of experience in a medical device Quality Engineering role.
• Demonstrated experience with failure analysis techniques for medical devices.
• Strong understanding of risk management principles and regulatory requirements for medical devices (e.g., FDA QSR, ISO 13485).
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across different teams.
• Ability to work independently and manage multiple tasks simultaneously.
• Attention to detail and a commitment to quality excellence.
• Ability to maintain up-to-date biohazardous material vaccinations, including Hepatitis A, B, and C, and any others deemed necessary by the company based on potential exposure risks.
• Experience with implantable medical devices.
• Knowledge of FDA IDE regulations.
• Familiarity with FDA complaint handling procedures during an IDA and post PMA.
• Experience with Six Sigma or other quality improvement methodologies.

About BrioHealth Solutions IncBrioHealth Solutions Inc., Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD®) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.