Senior Design Quality EngineerBrioHealth Solutions • Burlington, VT, US
Senior Design Quality Engineer
BrioHealth Solutions • Burlington, VT, US
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job_description.job_card.job_descriptionEnsure compliance with FDA QSR, ISO 13485, and global regulatory requirements for complaint investigations. Support complaint investigation processes during regulatory audits and inspections. Maintain knowledge of OSHA and CDC regulations for handling potentially biohazardous materials. Support regulatory reporting requirements related to FDA IDE regulations and post-PMA complaint handling. Drive continuous improvement initiatives in complaint handling and returned product analysis. Participate in process enhancements, including updating SOPs, refining metrics, and supporting change requests. Work closely with key quality and business stakeholders to ensure comprehensive product investigations. Stay current on industry standards and emerging best practices for medical device quality engineering. Log, track, and manage returned devices and peripherals. Perform failure analysis investigations using advanced techniques. Develop and implement preventive actions to minimize recurrence of product issues. Bachelor's degree in Engineering, Science, or a related field. 7+ years of experience in a medical device quality engineering role. Hands-on experience with failure analysis techniques for medical devices. Strong understanding of risk management principles and regulatory requirements (FDA QSR, ISO 13485). Experience with implantable medical devices and complaint handling during IDE and post-PMA phases. Knowledge of FDA regulatory processes, including complaint handling and CAPA methodologies. Strong analytical, problem-solving, and technical writing skills. Ability to work independently while effectively collaborating with cross-functional teams. Experience with Six Sigma or other quality improvement methodologies is a plus. Must be able to maintain up-to-date biohazardous material vaccinations (Hepatitis A, B, C, etc.), as required. Seniority level : Mid-Senior level Employment type : Full-time Job function : Quality Assurance Industry : Medical Equipment Manufacturing
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
J-18808-Ljbffr
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