Quality Compliance Intern
Type
Full time
Location
Job reference
Req-37734
Posted for
10 days ago
Make a meaningful difference to patients around the world. Our University Programs are designed to help early-career professionals contribute to solutions that transform patient lives. We also believe in investing in the future of our talented people across the globe, including early career professionals seeking to explore and establish themselves within the medical device industry. We’ll provide you with the opportunity to thrive in a dynamic environment where you can make innovative contributions. As Quality Compliance Intern with us, you’ll find motivation and inspiration in a culture that emphasizes passion for patients as you discover your own strengths.
Your main purpose will be to 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.
How you will make an impact:
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 o 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 o Prepare and submit final customer correspondence, after review by more senior team member
What you’ll need:
- Enrolled University student (Bachelor / Master) of Biomedical Engineering, Biotechnology, or any other related field, interested in medical device.
- In the last year of the degree.
- Comfortable working in English, proficiency preferred.
- Full-time (40h/week) availability for minimum 6 months.
- Problem-solving and critical thinking skills.
- Communication and relationship-building skills.
- Basic knowledge of medical terms and human anatomy.
- Big plus: knowledge of Medical Device Vigilance regulations, and regulatory reporting regulations.
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 Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).
The internship is paid and you will be eligible to participate in all activities from the Edwards Spanish Committee and access the Well-being Program. You'll also have possibility to do home office and enjoy all the amenities in our Paterna Office.
Wichtiger Hinweis für Kandidaten
COVID-Impfvorschrift
Edwards hat sich verpflichtet, die Anforderungen und Richtlinien unserer Regierungsbehörden einzuhalten und unsere gefährdeten Patienten und die Gesundheitsdienstleister, die sie auf der ganzen Welt behandeln, zu schützen. Aus diesem Grund ist für alle Positionen im Gesundheitswesen eine COVID-19-Impfung erforderlich, d. h. für alle, die direkt mit Patienten zu tun haben, und für alle, die im Rahmen ihrer Tätigkeit mit Gesundheitsdienstleistern zu tun haben. Wenn Sie eingestellt werden, müssen Sie als Einstellungsvoraussetzung nachweisen, dass Sie vollständig gegen COVID-19 geimpft sind oder eine gültige religiöse oder medizinische Befreiung von der Impfung haben. Diese Impfpflicht gilt nicht in Ländern, in denen es gesetzlich verboten ist, eine Impfung vorzuschreiben. In Ländern, in denen weniger Impfstoffe zur Verfügung stehen oder andere Anforderungen bestehen, können wir alternative Maßnahmen ergreifen, die die Sicherheit der Patienten und des medizinischen Personals optimieren, z. B. regelmäßige COVID-Tests oder spezielle Maskierungsanforderungen.
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