For our customer, a leading international pharmaceutical company based in Basel, we are looking for an experienced personality in the function of
Technical Quality Expert Medical Devices, parttime 30%, temporary 3-4 months
In this temporary, parttime (30%) role, you will provide Project Management and Medical Device expertise (with emphasis on Software as Medical Devices (SaMD)) to support the maintenance of the ISO 13485 and the QMS EU MDR certifications. You will support the Quality Integration Lead on the management of an integration project of a new SaMD asset in the company's portfolio.
- Support in the coordination of all activities associated with the maintenance and expansion of the ISO 13485 certification, as well as to the EU MDR certification
- Combine solid Medical Device expertise (SaMD knowledge preferred) with strong project management skills to support Quality Integration Lead of the SaMD integration project, interacting with a range of quality units and other stakeholders in the company
- Engage with the different stakeholders, tracking actions, producing periodic report progress status and material for presentation at management boards
- Review and provide SME input to critical documents in review and approval cycles
- Act in the corresponding IT systems (e.g. ESOPs-Documentum and AQWA-Trackwise)
- Degree in scientific or relevant discipline (BS or equivalent)
- Work experience in the pharmaceutical-, oder medical device industry
- Excellent knowledge and understanding of the relevant requirements for device and development, with a focus on SaMD
- Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards
- Project Management experience
- Demonstrated ability to collaboratively work in an interdisciplinary and multicultural team
- Fluent in English oral and written
Our customer offers
- Be part of a leading international pharmaceutical company
- You will work with cutting edge technologies, in a highly innovative and dynamic environment
- Learn from the best
Please apply online.
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