Edwards Lifesciences Sr. Specialist, Product Quality Clinician (TMTT) in Irvine, California
This is an exciting opportunity for an experienced clinician to join a team involved with Transcatheter Mitral & Tricuspid Therapies. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives. The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment.
This role will provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.
• Analyze complex event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure. May review complaint conclusions/closure statements and/or customer letters.
• 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
• Analyze complex clinical evaluation reports (CER) regulatory submissions, regulatory agency requests, and/or management report including ad hoc report
• Provide clinical input to Product Risk Assessments (PRA).
• Provide training to complaint staff on products and procedures and internal policies and procedures
• Support Product Safety to maintain Decision Rationale Matrix (DRM) and utilize DRM for reportability
• Provide knowledge transfer and product training for team members
• Other incidental duties: Maintain relevant education/training
Education and Minimum Requirements:
Bachelor's degree and 5+ years' relevant clinical experience supporting product quality in the medical device industry and/or relevant experience in a hospital/clinical environment (e.g., cardiac care, ICU, OR, or cardiovascular/endovascular interventions)
- Quality Clinician and complaints investigations experience supporting class III structural heart products within the medical device industry
Additional Talents and General Expectations:
• Excellent facilitation, presentation, and public speaking skills
• Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills with ability to drive achievement of objectives
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
• Proven successful project management skills
• Full knowledge and understanding of Edwards policies, procedures and guidelines
• Knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR EU MDR and other applicable regulatory requirements.
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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 15,000 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.