Assoc Spec, Quality Compliance
Edwards Lifesciences
Valencia, ES
hace 3 días
source : DirectEmployers Association

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.

Key Responsibilities : Investigate complaints with the support of higher level team member or managero Evaluate event to determine if it qualifies as a complainto Manage customer relationship and expectations during course of complaint investigation andresolution processo Assess complaint information provided and conduct additional investigation as needed and escalate asappropriateo Evaluate complaints for Medical Device Vigilance (MDV) to competent authoritieso Prepare and submit MDV reports to CA, after review by more senior team membero 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 formulateconclusionso 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 encounteredEducation and Experience : Bachelor's Degree or equivalent in in related field, 1 year years experience complaint handling-similar experience Required andExperience working in a medical device (cardiovascular, endovascular, or other critical care / surgical products), healthcare, or a related environment PreferredAdditional Skills :
  • 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 / controlEdwards 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.

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