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

🕒 Ontem

🏄 California, Massachusetts, +2 estados a mais – Remoto

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

💵 $126.000 - $178.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Edwards Lifesciences

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1958

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Medical Devices

A Edwards Lifesciences é líder global em inovações médicas centradas no paciente. A empresa é especializada em soluções para doenças de válvulas cardíacas, oferecendo produtos e serviços como válvulas cardíacas transcateter e tecnologias mitrais e tricúspides, além de soluções cirúrgicas para válvulas cardíacas. A Edwards Lifesciences também se concentra em tecnologias de cuidados críticos, incluindo monitoramento hemodinâmico, monitoramento remoto e monitoramento preditivo. A empresa realiza pesquisa clínica e está comprometida em melhorar a vida dos pacientes por meio de soluções inovadoras para doenças cardiovasculares, atuando, ao mesmo tempo, como cidadã corporativa responsável, com ênfase em filantropia corporativa global.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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