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Edwards Lifesciences: Associate Manager, Product Quality Clinician (Cath Lab / Ir / Cvor Registered

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

Edwards Lifesciences is looking for a Registered Nurse with hospital/clinical experience (e.G. cardiac care, ICU, OR, or cardiovascular/endovascular interventions) and/or previous related experience in a Medical Device Industry. The position will be within the fast-paced and growing business department, Transcatheter Heart Valve (THV). The Nurse will provide clinical expert knowledge and guidance to Quality Compliance and assisting with Quality Engineers with Product Quality Safety.This Associate Manager, Product Quality Clinician (Registered Nurse) will be a member of Complaint Handling and Post Market Surveillance/Risk Management team to provide clinical guidance/clinical expert knowledge to Quality, Engineering and other cross functional teams to understand the nature of complaints and possible health risks. In this role you will ensure appropriate investigation of product complaints and adverse events, in order to escalate potential manufacturing, design, labeling and training issues. You will also follow standard practices and procedures in analyzing data, interpreting and drawing conclusions, with the objective of gathering key information and communicating to cross-functional teams who will utilize the information for improvement of product and procedural outcomes.Job Functions:Provides medical/clinical guidance to complaint investigators and engineers 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 Communicates with Edwards Field Clinical Specialists, Edwards Sales Representatives, Physicians, Nurses and other hospital staff/customers, as needed Provides training to complaint investigators on patient anatomy and medical conditions, THV products and procedure, and internal policies and procedures 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 Authors and/or reviews complaint conclusions/closure statements and customer letters Assists with and helps manage procedural imaging reviews In aggregate, analyzes and interprets complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report Prepares ad hoc report summaries 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 and Risk Management WorksheetsProvides clinical input to Product Risk Assessments, and participate in Risk Management Councils and Quality Boards Aid in response to Regulatory Agencies who inquire about complaint /Risk Management related issuesRequired Qualifications:Bachelor’s degree (Will consider a combination of some college education and related work experience as a substitute for a Bachelor’s degree). Minimum of 8 years of hospital/clinical experience is required.Preferred Qualifications:Nursing degree or related disciplineCardiac Care, CATH Lab, ICU, Operating Room, or Cardiovascular/Endovascular interventions experience highly preferred. Medical Device Industry experience preferredExperience in leading teams preferred Excellent written and oral English communication skills Ability to read and interpret documents such as Product Instructions for Use, Training and Procedure Manuals Ability to write routine MDR reports and routine correspondence Ability to speak effectively before groups of employees of organization Experience training groups Knowledge of computer application programs including Excel, PowerPoint and Word Ability to interpret a variety of instructions furnished in written, oral, or diagram form.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences, Irvine , Edwards Lifesciences: Associate Manager, Product Quality Clinician (Cath Lab / Ir / Cvor Registered , Other , Irvine, California

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