Senior Lead Quality Analyst - Post Market Surveillance
EBR Systems, Inc.United States
Posted October 21, 2025
117700 - 151300 USD year
Full Time
About the Company
EBR Systems, Inc. is a medical device company specializing in innovative cardiac rhythm management solutions, including the WiSE Cardiac Resynchronization Therapy system. The company develops leadless left ventricular CRT devices and provides comprehensive clinical support, training, and technical guidance to improve patient outcomes.
Job Description
This Senior Lead Quality Analyst – Post Market Surveillance role supports global complaint handling and post-market surveillance for the WiSE CRT System and components, working closely with the Complaint Manager. The role involves SMEing patient evaluation, CAPA management, risk mitigation, and ensuring compliance with regulations like FDA 21 CFR 803/820, EU MDR, and TGA. Requires a strong nursing background and expertise in cardiology and cardiac rhythm management.
Requirements
- Bachelor’s degree in scientific discipline (Registered Nurse – RN required)
- Minimum 5 years of experience in Post Market Surveillance, Complaint Handling, within the medical-device industry
- Experience with Active Implantable Medical Devices (AIMDs) specifically pacemaker or Cardiac Resynchronization Therapy (CRT) systems
- Strong working knowledge of FDA 21 CFR 803/820, EU MDR 2017/745, MEDDEV 2.12-1, ISO 13485, ISO 14971, TGA, and PMDA requirements
Benefits
- Medical, dental, and vision insurance
- 401(k) matching
- Paid Time Off
- Competitive salary
- Employee stock options
- Life & AD&D and long term disability insurance
- Education assistance
- Voluntary commuter benefits and pet insurance
