Quality Compliance Intern

hace 2 semanas

Valencia, España Edwards Lifesciences A tiempo completo

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.

**Job reference**:

- Req-37734

**Type**:

- Full time

**Location**:

- Spain-Valencia

**Posted for**:

- 1 day ago

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