Manager, Post-Market Quality
Element Science, Inc., Redwood City, CA, United States
Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.
Summary
The Post Market Quality Manager is responsible for the end-to-end lifecycle of product feedback and quality issues. This role will lead the complaint process from initial intake and determination through investigation, regulatory reportability assessment and complaint closure including 14-day customer letters where required while maintaining regulatory compliance. This role will also drive trending of post-market data and translate into actionable data for Management and cross-functional stakeholders.
Responsibilities
Triage Oversight: Own the intake process for all incoming product feedback, distinguishing between general inquiries and events meeting the formal complaint definition per internal procedures.
Complaint Initialization: Ensure each confirmed complaint is properly opened, coded and assigned within the complaint management system per internal procedures.
Workflow Management: Monitor queue status and throughput; ensure no reportable events or high severity complaints are delayed at intake. Ensure reportable complaints are reported within the mandated regulatory requirements.
Investigation, Reportability & Closure
Investigation Oversight: Manage the end-to-end investigation process, ensuring technical teams identify failure modes and that documentation meets audit-ready standards. Maintain investigation completeness cycle time within SLA targets.
MDR Assessment: Lead the assessment of adverse events for FDA reportability per internal procedures. Ensure Medical Device Reports (MDRs) are submitted accurately and within statutory timelines.
EU Vigilance Reporting: Oversee EU MDR Vigilance reporting as applicable to Element Science regulatory scope and authorized representative obligations.
Complaint Closure: Ensure each complaint is closed with complete investigation findings, root cause determination, risk assessment and appropriate regulatory assessment. Maintain closure cycle time within SLA targets.
Risk Management: Evaluate whether complaint trends necessitate an escalation to the Corrective and Preventive Action (CAPA) system or other risk-based containment measures.
Post-Market Analysis & Metrics
Complaint Metrics: Responsible for publishing weekly, monthly and quarterly complaint metrics for internal stakeholders and Management Review.
Trend Analysis: Perform Post-Market Surveillance (PMS) analysis to identify emerging risks or "signals" that were not previously identified in the Risk Management File. Escalate findings promptly.
Cross-Functional Reporting: Present findings to Executive Leadership and Quality Management Reviews, providing actionable insights that influence Engineering, Clinical and Manufacturing priorities.
DMEPOS Compliance
CMS Quality Standards: Ensure the complaint management system remains in alignment with CMS DMEPOS Quality Standards as implemented through Element Science CHAP accreditation, specifically regarding the timely resolution of grievances and the documentation of beneficiary interactions.
Qualifications
Bachelor's degree in Engineering, Life Sciences, or a related technical field.
5+ years in Quality Assurance or Regulatory Affairs within a regulated industry (Medical Device, Biotech, or Pharma) with 2+ years of managing direct reports.
Preferred experience with Class III PMA devices and/or AI/ML Software as Medical Device (SaMD)
Familiarity with CMS DMEPOS Quality Standards.
Demonstrated experience linking complaint trends to CAPA initiation and risk management file updates.
Deep expertise in FDA 21 CFR Part 803 (MDR), Part 820, and ISO 13485/14971 including hands on experience with authoring MDRs.
Working knowledge of EU MDR Vigilance reporting obligations.
Experience managing complaints in a validated electronic management system or quality management system (e.g. Salesforce, Master Control, ETQ or equivalent)
Proficiency in statistical trending, complaint metrics, and data visualization tools, including excel.
Ability to present complex post-market data clearly to management and cross functional stake holders.
Benefits
Stock Options
90% employer-paid medical, dental, and vision insurance
Company-paid Basic Life Insurance
401(k) retirement plan (Traditional and Roth)
Competitive Paid Time Off
Paid Holidays
FSA (Flexible Spending Accounts)
HSA (Health Savings Account)
Employee Assistance Program through PEO
Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job.
At this time, we are unable to offer relocation assistance at Element Science.
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Summary
The Post Market Quality Manager is responsible for the end-to-end lifecycle of product feedback and quality issues. This role will lead the complaint process from initial intake and determination through investigation, regulatory reportability assessment and complaint closure including 14-day customer letters where required while maintaining regulatory compliance. This role will also drive trending of post-market data and translate into actionable data for Management and cross-functional stakeholders.
Responsibilities
Triage Oversight: Own the intake process for all incoming product feedback, distinguishing between general inquiries and events meeting the formal complaint definition per internal procedures.
Complaint Initialization: Ensure each confirmed complaint is properly opened, coded and assigned within the complaint management system per internal procedures.
Workflow Management: Monitor queue status and throughput; ensure no reportable events or high severity complaints are delayed at intake. Ensure reportable complaints are reported within the mandated regulatory requirements.
Investigation, Reportability & Closure
Investigation Oversight: Manage the end-to-end investigation process, ensuring technical teams identify failure modes and that documentation meets audit-ready standards. Maintain investigation completeness cycle time within SLA targets.
MDR Assessment: Lead the assessment of adverse events for FDA reportability per internal procedures. Ensure Medical Device Reports (MDRs) are submitted accurately and within statutory timelines.
EU Vigilance Reporting: Oversee EU MDR Vigilance reporting as applicable to Element Science regulatory scope and authorized representative obligations.
Complaint Closure: Ensure each complaint is closed with complete investigation findings, root cause determination, risk assessment and appropriate regulatory assessment. Maintain closure cycle time within SLA targets.
Risk Management: Evaluate whether complaint trends necessitate an escalation to the Corrective and Preventive Action (CAPA) system or other risk-based containment measures.
Post-Market Analysis & Metrics
Complaint Metrics: Responsible for publishing weekly, monthly and quarterly complaint metrics for internal stakeholders and Management Review.
Trend Analysis: Perform Post-Market Surveillance (PMS) analysis to identify emerging risks or "signals" that were not previously identified in the Risk Management File. Escalate findings promptly.
Cross-Functional Reporting: Present findings to Executive Leadership and Quality Management Reviews, providing actionable insights that influence Engineering, Clinical and Manufacturing priorities.
DMEPOS Compliance
CMS Quality Standards: Ensure the complaint management system remains in alignment with CMS DMEPOS Quality Standards as implemented through Element Science CHAP accreditation, specifically regarding the timely resolution of grievances and the documentation of beneficiary interactions.
Qualifications
Bachelor's degree in Engineering, Life Sciences, or a related technical field.
5+ years in Quality Assurance or Regulatory Affairs within a regulated industry (Medical Device, Biotech, or Pharma) with 2+ years of managing direct reports.
Preferred experience with Class III PMA devices and/or AI/ML Software as Medical Device (SaMD)
Familiarity with CMS DMEPOS Quality Standards.
Demonstrated experience linking complaint trends to CAPA initiation and risk management file updates.
Deep expertise in FDA 21 CFR Part 803 (MDR), Part 820, and ISO 13485/14971 including hands on experience with authoring MDRs.
Working knowledge of EU MDR Vigilance reporting obligations.
Experience managing complaints in a validated electronic management system or quality management system (e.g. Salesforce, Master Control, ETQ or equivalent)
Proficiency in statistical trending, complaint metrics, and data visualization tools, including excel.
Ability to present complex post-market data clearly to management and cross functional stake holders.
Benefits
Stock Options
90% employer-paid medical, dental, and vision insurance
Company-paid Basic Life Insurance
401(k) retirement plan (Traditional and Roth)
Competitive Paid Time Off
Paid Holidays
FSA (Flexible Spending Accounts)
HSA (Health Savings Account)
Employee Assistance Program through PEO
Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job.
At this time, we are unable to offer relocation assistance at Element Science.
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