Edwards Lifesciences Product Quality Clinican in Valencia, Spain
Provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.
• Provide medical/clinical guidance and final direction to complaint staff related to event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure. May review complaint conclusions/closure statements.
• Educate complaint staff to understand the medical aspects of complaint information and associated procedures including health risks.
• May provide training to complaint staff on patient anatomy and medical conditions, products and procedures, and internal policies and procedures.
• Provide support in complaint data and relevant clinical information for regulatory submissions or regulatory agency requests.
• Provide training for other Clinicians Quality Compliance and Quality Specialists.
• 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
• Support Product Safety to maintain Decision Rationale Matrix to guide complaint staff and provide final direction on reporting decisions
• Other incidental duties
Education and Experience:
Bachelor's Degree or Equivalent in in related field , 4-5 years years experience of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (i.e. cardiac care, ICU, OR, or cardiovascular/endovascular interventions) Required
Previous experience working in a large manufacturing company Preferred
• Strong presentation and public speaking skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System)
• Excellent documentation and communication skills and interpersonal relationship skills
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of International Quality System Regulations
• Working knowledge of Medical Device regulations, and other applicable regulatory requirements.
• Provides consultancy to quality compliance team
• Consult in project setting within specific sections of quality compliance area
• 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 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.