As a 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.
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 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
Required Education & Skills:
Bachelor’s degree required (nursing or related discipline preferred). Will consider a combination of education and related work experience as a substitute for a Bachelor’s degree.
Minimum of 8 years of hospital/clinical experience is required.
Cardiac Care, CATH Lab, ICU, Operating Room, or Cardiovascular/Endovascular interventions highly preferred.
Experience 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.
Internal Number: 017451
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
