Edwards Lifesciences · 23 hours ago
Quality Compliance Specialist, MDR Reporting
United States
Full-time
Remote
Mid Level
$68K/yr - $96K/yr
3+ years expEdwards Lifesciences is a company dedicated to developing groundbreaking technologies that ensure the highest standards of integrity and safety. The Quality Compliance Specialist will evaluate global complaint information, conduct investigations, and prepare and submit Medical Device Reporting (MDR) reports to the FDA, while optimizing product development to impact patients worldwide.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate
Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
Evaluate complaints for Medical Device Reporting (MDR)
Prepare and submit MDR reports to FDA
Identify problems and lead projects to improve processes, procedures, and/or practices; recommend and resolve solutions, including devising new approaches to problems encountered
Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
Evaluate event to determine if it qualifies as a complaint
Manage customer relationship and expectations during course of complaint investigation and resolution process
Prepare and submit final customer correspondence
Lead and plan agenda for and run weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint
Analyze and/or audit complaint data/files and may develop reports
Lead the investigation of complaints that include all complex scenarios:
Other duties assigned by Leadership (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is needed)
Qualification
Required
Bachelor's degree plus five (3) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting); or equivalent work experience based on Edwards criteria
Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment/industry experience
Preferred
Experience submitting Medical Device Reports
Proficient knowledge of medical terms and human anatomy
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
Proven expertise in MS Office Suite and ability to operate general office machinery
Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
Demonstrated problem-solving, critical thinking, and investigative skills working relationships
Substantial knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
Ability to manage confidential information with discretion
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences 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 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Andrew Greene
Vice President, Strategy
Recent News
2026-02-04
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
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