Senior Lead Quality Analyst – Post Market Surveillance

Job not on LinkedIn

October 24

Apply Now

Receive Emails with Similar Jobs

EBR Systems, Inc.

WebsiteLinkedInAll Job Openings

EBR Systems, Inc. is driven to deliver superior treatment for millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. The company’s initial product, the WiSE® CRT System, is a first-of-its-kind medical device developed to overcome the limitations of traditional Cardiac Resynchronization Therapy (CRT) in heart failure patients by eliminating the need for a lead to the heart’s left ventricle and the associated complications of that lead.

51 - 200 employees

📋 Description

• Supports the Complaint Manager in managing, coordinating, and continuously improving global complaint handling and post-market surveillance processes for the WiSE CRT System • Acts as a Subject Matter Expert (SME) for complaint investigations, root-cause analysis, and complaint related CAPA’s • Ensures that technical findings are translated into clear, accurate, and meaningful summaries for regulatory audiences • Applies clinical judgment to assess event severity and reportability under various regulations • Leads or contributes to root-cause analyses using methodologies such as 5 Whys, Fishbone, and Fault Tree Analysis • Ensures proper linkage between complaints, CAPAs, and risk management documentation • Compiles, analyzes, and trends complaint data to detect emerging risks, product reliability issues, and safety signals • Develops and maintains Post Market Surveillance Plans, PMS Reports, and Management Review metrics • Acts as audit liaison and subject-matter expert for PMS and complaint-handling processes during internal and external audits

🎯 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 • Proven expertise in root-cause investigation, CAPA management, risk management, and PMS report compilation • Deep understanding of cardiology and cardiac rhythm management therapies • Ability to integrate clinical, technical, and regulatory perspectives into complaint evaluations • Advanced proficiency in Microsoft Excel (pivot tables, macros, formulas, charting) and PowerPoint for metric and trend visualization • Familiarity with Microsoft Planner for project tracking and task management • Excellent written communication skills with the ability to simplify complex technical information • Analytical mindset with exceptional attention to accuracy and data integrity • Demonstrated ability to work cross-functionally and manage multiple priorities in a fast-paced, regulated environment.

🏖️ Benefits

• Medical, dental, and vision insurance provided at no cost for employee-only coverage • 401(k) matching plan • Paid Time Off – starting at 3 weeks per year • Competitive salary with opportunities for career growth • Employee stock options • Life & AD&D and long term disability insurance • Education assistance • Voluntary commuter benefits and pet insurance • Weekly company lunches and occasional happy hour events • Meaningful work and much more!