Edwards Lifesciences Analyst, Quality Systems in Valencia, Spain
Improve and implement quality systems processes, including applications, documentation and training.
• Identify and implement business process improvement solutions for Quality systems, including developing changes to procedures, to improve operation and user experience, while supporting the integrity of the business process.
• Provide first-level help desk support to users, e.g., CAPA, including troubleshooting system issues, (e.g., system access, systems response) before escalating to IT if needed
• Recommend changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others
• Lead small-scope projects and/or elements of large-scope projects, including developing and/or scheduling key milestones, securing and allocating resources, and/or representing quality management on cross-functional teams
• Deliver system training programs and contribute to the development of training programs and materials
• Collect and generate metrics, and draw inferences for system improvement opportunities
• Other incidental duties
Education and Experience:
Bachelor's Degree in in related field , 3 years years experience of previous experience Required
Experience in a quality and/or manufacturing environment in the medical device industry Preferred
• computer skills in MS Office Suite
• Good project management skills and related software tools preferred
• Good written and verbal communication skills including negotiating and relationship management skills
• Good problem-solving and critical thinking skills
• Solid knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems
• Solid knowledge of medical or pharmaceutical regulations as relating to documentation
• Solid understanding of medical devices regulations (e.g., FDA (21 CFR Part 820) and ISO13485)
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness
• 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.