Quality Assurance

About Dedalus

We are a Global European Health Software Company and one of the largest in the world’s largest. Our shareholding structure guarantees financial capacity and stability, thanks to the investment from Ardian, the largest private investment company in Europe and the fourth largest in the world. In 2016, Dedalus decided to accelerate its expansion strategy by focusing on the accelerating demand for innovative and comprehensive solutions to support the digital transformation of the healthcare ecosystem Working across the whole continuum of care and offering Open Standards-based solutions, Dedalushelps the healthcare organisations to deliver new models of care. The benefit of our approach is enabling the delivery of better healthcare outcomes. We have over 50 years’ experience of delivering healthcare software and services to healthcare customers. Our software is used widely across the world, managing more than 3 billion diagnostic results, 333 million Patient Records, 28 million Inpatient and 32 million Emergency admission, and in primary care, we serve more than 79 million Citizens.

Dedalus at a glance

Today, Dedalus employs more than 6.200 highly skilled qualified people; it has the largest software R&D team in the industry in Europe with more than 2.100 staff. Thanks to our portfolio of leading next-generation solutions, Dedalus covers the entire spectrum of healthcare professionals’ needs, and today we support over 6.300 hospitals and 5.300 laboratories worldwide. At Dedalus, we understand the importance of collaboration in the new models of care delivery. These new models are founded on delivering continuity of care throughout a citizen’s life, integrating care around the patient through the whole healthcare ecosystem and supporting patient engagement in their care. Health systems require capabilities to support remote care, with dynamic clinical best practices and real-time knowledge sharing at the point of care.

Our Name

The myth says that, in 2000 BC, Daedalus, the first known architect in history, designed and built the Palace of Knossos: an incredible building with an amazing labyrinth constructed inside. The labyrinth represents the journey to prosperity and the search for knowledge. In 1220 AD, the first Gothic cathedral was completed in Chartres (France). This amazing building, once again with a labyrinth inside, represents the journey to knowledge.Dedalus is the name of our company. It is written in Latin, the universal language of Europe and the Middle East for more than 1500 years. The Dedalus company seeks to create a world-leading community based on the experience and expertise of our clients and our team that together will forge a pathway to advance knowledge and tackle the opportunities of modern healthcare.Our passion and mission, expressed in our software-based solutions, is to enable healthcare professionals to build and share clinical knowledge.Every day, we do something special by helping carers and health professionals to provide better care for the communities they serve.LIFE FLOWS THROUGH OUR SOFTWARE

**Position**:
We are currently looking for a **Quality Assurance & Regulatory Affairs Specialist (M/F/d) - Intern.**

He/she will provide guidance and execute regulatory plans and strategies, working with the project core team. He/she will also be accountable for the implementation of the premarket regulatory procedures and the compilation of regulatory clearance documentation to achieve timely regulatory clearances.

**Main Tasks, as a support to the QARA Team**:

- Provides quality assurance of design (Design Authority)
- Participates as a mandatory core team member on premarket Product Development teams to assure regulatory and process conformance for new and maintenance projects
- Guides Product Managers and Project Managers regarding compliance issues and ensure that decisions are properly documented and is following its processes
- Ensures that Product Quality Strategy is completed compliantly and thoroughly
- Creates and maintains the key regulatory deliverables
- Manages the creation and maintenance of the risk management file
- Verify that all risk mitigations are implemented in the course of the project
- Conducts and document quality planning for new products
- Reviews product documentation (e.g. design history file) to ensure compliance with regulations
- Makes recommendation on product release to QARA management
- Provides compliant design control files and defend pre market activities during external regulatory inspections
- Identifies ongoing training needs of the team and provide training as required
- Takes actions if there are process issues for related premarket/design control processes
- Ensures that the NC/CAPA process is followed as required and take actions if there are product or project issues
- Provides KPI data for internal reporting on project status and regulatory submissions as QMR and scorecard input for pre-market activities
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