Quality Compliance Intern

Edwards Lifesciences, a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, is looking for an enthusiastic student, who would like to join the Quality team in Valencia and help manage our complaint handling. That includes fulfillment of applicable medical device regulations in the region and evaluation of events for reportability to applicable regulatory bodies.

**Location**: Valencia, Spain

**Duration**: min. 6 months, fulltime

**Start date**: around September

Essential Job Functions
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 Reporting to competent authorities
Prepare and submit reports to Competent Authorities, 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

**Required Skills**:
Enrolled in studies related to Biomedical and Biotechnological Engineering (Degrees/Masters) or any degree related to health
Good English skills written and spoken
Good problem-solving and critical thinking skills
Basic knowledge of medical terms and human anatomy
Its is valued having knowledge of Medical Device Vigilance regulations, and regulatory reporting regulations
Attention to detail

What is it like to work at Edwards Lifesciences in Spain?
As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.
We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the EdwardsNetwork of Women, Edwards Foundation charity team, sustainability activities, and others).

Edwards Lifesciences in Spain also offers the following benefits:
Competitive Compensation

Flexible working hours, remote working

Meal Vouchers

Comprehensive Wellness programme including gym membership reimbursement, fresh fruit in the office, yoga lessons, subsidized massages, mindfulness sessions, educational events, charity activities and much more.

Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.

About Edwards Lifesciences

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 18,500 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.

COVID Vaccination Requirement

**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

**Know your Rights**: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice