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Senior Lead Quality Analyst - Post Market Surveillance
Fully Remote
Description
Summary of the Position
The Sr. Lead Quality Analyst – Post Market Surveillance (PMS) supports the Complaint Manager in managing, coordinating, and continuously improving global complaint handling and post-market surveillance processes for the WiSE CRT System and associated components.
This individual acts as a Subject Matter Expert (SME) for complaint investigations, root‑cause analysis, and complaint related CAPA’s, ensuring that technical findings are translated into clear, accurate, and meaningful summaries for regulatory audiences.
The role requires strong clinical judgment to assess event severity and reportability under FDA (21 CFR 803/820), EU MDR 2017/745, TGA (Australia), and PMDA (Japan) regulations. A Nursing degree is required, along with in‑depth knowledge of cardiology, cardiac rhythm management, and Active Implantable Medical Devices (AIMDs).
Essential duties and responsibilities include, but are not limited to, the following:
- 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.
Other Duties and Responsibilities
- 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.
Education and Required Experience
- 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.
- Robust 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.
Knowledge, Skills, and Abilities
- 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.
Salary Range
$117,700 - $151,300
Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Additional compensation may include bonuses and equity, along with a comprehensive benefits package.
EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee‑based recruitment services. Please refrain from solicitations at this time.
About the Company
What if your work doesn’t just support innovation—what if it changes lives?
At EBR Systems, Inc., we are not imagining that future—we are building it. We are the team behind the world’s first FDA approved, leadless left ventricular endocardial pacing device for heart failure. It’s a breakthrough redefining what’s possible in heart care, and it’s just the beginning!
We don’t just create game‑changing medical devices—we grow people. Patients come first in everything we do. You will be empowered to solve real problems and to do meaningful work that truly makes a difference.
If you are driven by purpose, excited by challenge, and ready to shape the future of cardiac technology, we want to hear from you. Visit us at to learn more—and join us in our work Empowering Physicians, Powering Hearts.
EBR Systems, Inc. offers a great place to work as well as generous benefits and growth opportunities:
- 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
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