Edwards Lifesciences Clinician Product Quality in Irvine, California
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.
•Authors clinically based product specific scripts 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, Critical Care products and procedure, and internal policies and procedures.
•Provides complaint training to Sales, Marketing and other customer facing staff.
•Works with VP Product Safety to maintain Decision Rationale Matrix to guide complaint handlers in reporting decisions. Reviews/assists with reporting decisions.
•Reviews complaint codes, complaints and MDR reports.
•Authors and/or reviews complaint conclusions/closure statements and customer letters.
•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 Critical Care engineering documentation.
•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.
Required Skills, Experience and Education:
Requires a minimum of 8 years of hospital/clinical experience: cardiac care, ICU, OR, or cardiovascular/endovascular interventions.
Experience in leading teams preferred.
A bachelor's degree in nursing preferred. Will consider a combination of education and related work experience.
Knowledge of computer application programs including Excel, PowerPoint and Word processing.
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 correspondence.
Ability to speak effectively before groups of employees of organization.
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.
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 13,000 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.