Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN

Edwards Lifesciences•Irvine, MA

3d•$126,000 - $178,000•Remote

About The Position

This position offers the flexibility of being fully remote, but the selected candidate must be currently residing within the United States. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. As a Manager, Product Quality Clinician, you 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.

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

Nice To Haves

RN with Cath Lab, CVOR, or CVICU nursing experience
Experience leading cross-functional teams
Ability to read and interpret documents such as Product Instructions for Use, Training and Procedure Manuals
Ability to write routine MDR (Medical Device Reports) and routine correspondence
Ability to interpret patient medical records and clinical data to assess adverse events and potential device-related risks
Ability to speak effectively before groups of employees of organization
Experience training groups
Knowledge of computer application programs including Excel, PowerPoint and Word
Excellent written and oral English communication skills

Responsibilities

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.
Author and/or review 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
Obtain and evaluate 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
Authors and/or reviews complaint conclusions/closure statements and customer letters
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
Aid in response to Regulatory Agencies who inquire about complaint /Risk Management related issues