Manager, Product Quality Clinician – Medical Device, Complaint Handling, Cardiovascular RN

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🏄 California, Massachusetts, +2 more states – Remote

🏄 California – Remote 🍂 Massachusetts – Remote ❄️ Minnesota – Remote 🤠 Texas – Remote

💵 $126k - $178k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Provides medical/clinical guidance to complaint investigators and engineers related to event interpretation, event investigation, proper coding, required regulatory reporting (Medical Device Reports, Medical Device Vigilance, etc.), and complaint closure. • Authors and/or reviews complaint conclusions/closure statements and customer letters. • May assist with and help manage Imaging Reviews • Educates complaint investigators to understand nature of events and possible health risks • Interprets complaint data for complaint investigators, engineers, and other Quality department personnel • Authors clinically based product specific scripts to guide complaint investigators in appropriate investigational paths • Obtains and evaluates information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution • Provides training to complaint investigators on patient anatomy and medical conditions, and THV (Transcatheter Heart Valve) products and procedure • Provides complaint training to Sales, Marketing and other customer facing roles • Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint investigators with reporting decisions. • Reviews complaint codes and FDA Medical Device Reports, reviews and assists with reporting decisions • Analyzes and interprets complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report • Performs Complaint Trending Analyses and participates in Quality Metrics Review and Quality Data Review meetings where complaints are discussed • Communicates complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development in support of complaint investigations • Participates in review of/provides clinical guidance for FMEAs (Failure Mode & Effects Analysis) and Risk Management Worksheets • Provides clinical input to Product Risk Assessments, and participate in Risk Management Councils and Quality Boards • Aids in response to Regulatory Agencies who inquire about complaint /Risk Management related issues

🎯 Requirements

• Bachelor’s degree plus 8 years of relevant experience or equivalent work experience based on Edwards’ criteria • Current or previous Registered Nurse (RN) - active license not required • Cardiac patient care experience (e.g., Telemetry, Step-Down ICU, Treadmill lab, Cardiac Rehab Floor, Heart Failure units, Cardiac Recovery, or similar) • Medical device industry experience in Quality/Compliance, with a strong preference for complaint handling, complaint investigation, and/or post-market surveillance

🏖️ Benefits

• Competitive salaries • Performance-based incentives • A wide variety of benefits programs to address the diverse individual needs of our employees and their families