Edwards Lifesciences Assoc. Spec. Quality Compliance - Trainee in Valencia, Spain
- Fulfill applicable medical device regulations in the region, ISO13485 and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.
Investigate complaints with the support of higher level team member or manager
Evaluate event to determine if it qualifies as a complaint
Manage customer relationship and expectations during course of complaint investigation and resolution process
Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate
Evaluate complaints for Medical Device Vigilance (MDV) to competent authorities
Prepare and submit MDV reports to CA, after review by more senior team member
Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
Prepare and submit final customer correspondence, after review by more senior team member
Other incidental duties; May identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered
Bachelor's Degree or equivalent in related field with 1 year of complaint handling-similar experience.
Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment is a plus.
Good computer skills in MS Office Suite and ability to operate general office machinery
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Moderate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
Basic knowledge of medical terms and human anatomy
Full knowledge of Medical Device Vigilance regulations, and regulatory reporting regulations
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Ability to manage confidential information with discretion
Attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment with guidance
Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
Ability to build stable internal/external working relationships
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.