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.
The Product Quality Clinician is supporting the Medical investigation of the events occurred in the field;
Point of view of the medical problem where Edwards products have been involved.
Availability to interpret medical records and medical images (ECHO, CT, ECG, etc….)
Skill writing medical reports and conclusions
Education and Experience:
• Bachelor's/Master Degree in related field (Medicine/ Nursing) with 8-10 years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (i.e. cardiac care ward, ICU, OR, or cardiovascular/endovascular interventions such Cath lab)
• Project management skills
• Excellent facilitation, presentation, and public speaking skills
• Expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System)
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• 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
• 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.