As the Associate Manager, Product Quality Clinician in the Transcatheter Mitral & Tricuspid Therapies (TMTT) division you will be a member of Complaint Handling and Post Market Surveillance/Risk Management team to provide clinical expert knowledge and clinical guidance 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 complaints and adverse events in order to escalate potential manufacturing, design, labeling and training issues. You will also help develop and maintain 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.
Key responsibilities include:
Provides Medical/Clinical Guidance to Complaint Staff and Engineers; Educates complaint staff to understand nature of complaints and possible health risks; Interprets complaint data for Complaint handlers, complaint investigators and other Quality department personnel.
Participate in the development and maintenance of the processes and procedures that govern the complaint handling system.
Authors clinically based product specific documentation to guide complaint handlers in appropriate investigation.
Communicates with Edwards Clinical Specialists, Edwards Sales Staff, Physicians, Nurses and other hospital staff/customers, as needed.
Provides training to Complaint Handling staff on patent anatomy and medical conditions, CSS products and procedure, and internal policies and procedures.
Provides complaint training to Sales, Marketing and other customer facing staff.
Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint handlers in reporting decisions. Reviews/assists with reporting decisions.
Reviews complaint codes and MDR reports.
Authors and/or reviews complaint conclusions/closure statements and customer letters.
Assists with and helps manage 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 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 CSS FMEAs.
Provides clinical input to Product Risk Assessments (PRA), and participate in Risk Management Councils and Quality Boards.
Aid in response to Regulatory Agencies who inquire about complaint /Risk Management related issues.
Education, Experience and Skills:
Bachelor's Degree in related field with 8 years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (e.g. cardiac care, ICU, OR, or cardiovascular/endovascular interventions), required
Medical device industry experience is preferred and will be considered as partial substitute for clinical experience.
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 processing.
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, Californi...a, 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.