[Remote] Quality Compliance Specialist, MDR Reporting

Note: The job is a remote job and is open to candidates in USA. Edwards 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.

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)

Skills
• 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
• 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 Overview
• Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring. It was founded in 1958, and is headquartered in Irvine, California, USA, with a workforce of 10001+ employees. Its website is http://www.edwards.com.

Company H1B Sponsorship
• Edwards Lifesciences has a track record of offering H1B sponsorships, with 81 in 2025, 70 in 2024, 42 in 2023, 65 in 2022, 44 in 2021, 28 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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