How you´ll make an impact
- Verify requirements for review questionaries, procedures, regulatory documents (to verify the compliance of EW Quality requirements) and perform pre-approval.
- When some requirement/information is missing, communicate and get the information from internal or external stakeholders.
- Improve the data base of Quality Team for Distributor Management to support the monthly reports.
- Support to QA team to prepare materials to training regarding QMS to train Distributors.
- Support QA team for follow up of findings from Distributor Audits to comply with deadlines and action plan.
- Support QA team for follow up of findings from Internal Audits of CAPA to comply with deadlines and action plan.
What you will need
- Still enrolled in studies (missing 6 months to finalize) or preferable bachelor’s degree recently completed, any degree related to Healthcare.
- Comfortable working in English (to perform in meetings and read materials)
- Full-time (40h/week) availability for min. 9 months
- Problem-solving and critical thinking skills
- Communication and relationship-building skills
- Basic knowledge of medical terms and Quality Management Systems
- Knowledge in inspection of Medical Device products
- Knowledge of Medical Device regulations
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.
Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.
Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.
For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
