EBR Systems, Inc. · 2 months ago
Senior Lead Quality Analyst - Post Market Surveillance
United States
Full-time
Remote
Senior Level, Lead/Staff
$118K/yr - $151K/yr
5+ years expEBR Systems, Inc. is a pioneering company in cardiac technology, known for developing innovative medical devices. The Sr. Lead Quality Analyst – Post Market Surveillance plays a crucial role in managing and improving global complaint handling and post-market surveillance processes, acting as a Subject Matter Expert for complaint investigations and ensuring regulatory compliance.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Serve as SME for complaint investigations, ensuring consistency in root-cause determination and alignment with CAPA and risk files
Support the Complaint Manager in daily complaint handling, ensuring global regulatory compliance
Review engineering reports and translate technical findings into clear, relevant summaries for regulatory submissions and clinical communication
Apply clinical judgment to assess event severity, patient outcome, and reportability (MDR, Vigilance, TGA, PMDA)
Lead or contribute to root-cause analyses using methodologies such as 5 Whys, Fishbone, and Fault Tree Analysis
Ensure proper linkage between complaints, CAPAs, and risk management documentation (dFMEA, Hazard Analysis)
Compile, analyze, and trend complaint data to detect emerging risks, product reliability issues, and safety signals
Develop and maintain Post Market Surveillance Plans, PMS Reports, and Management Review metrics
Act as audit liaison and subject-matter expert for PMS and complaint-handling processes during internal and external audits
Continuously improve PMS and complaint-handling procedures, templates, and data systems
Contribute to risk-management reviews and design changes based on post-market data
Support automation and visualization of complaint data using Excel charts, Microsoft Planner, and PowerPoint visual summaries
Perform other related duties as assigned
Qualification
Required
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
Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms
Required to stoop, kneel, bend, crouch and lift up to 20 pounds
Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus
Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels
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!
Company
EBR Systems, Inc.
EBR Systems, Inc.
51-200 employees
H1B Sponsorship
EBR Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$248.68MKey Investors
Thomas FogartyDelphi Ventures
2025-06-18Post Ipo Equity· $13M
2025-05-22Post Ipo Equity· $35.83M
2021-07-29IPO
Leadership Team
Allan Will
Executive Chair of the Board of Directors (previously CEO)
John McCutcheon
President and CEO
Recent News
Morningstar.com
2025-10-14
Company data provided by crunchbase