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Edwards Lifesciences logo
Edwards Lifesciences

Global leader in the medical device industry with a patient-focused culture of innovation

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

ManagerManagerFull TimeRemoteLeadTeam 10,001+Since 1958H1B SponsorCompany SiteLinkedIn

Location

California + 3 moreAll locations: California | Massachusetts | Minnesota | Texas

Posted

24 days ago

Salary

$126K - $178K / year

Seniority

Lead

Bachelor Degree8 yrs expEnglish

Job Description

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

Edwards Lifesciences

• 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

Job 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

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