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Quality Assurance Specialist | 100%

Ypsomed AG

Employment type
Full-time
Location
Burgdorf
First posted
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At Ypsomed, we shape the future of medical technology together - with the goal of sustainably improving the quality of life for people with chronic illnesses. We promote an open and inclusive corporate culture in which diversity is valued and new perspectives are welcome. Our employees take responsibility, work interdisciplinary and develop innovative solutions with real social added value. In this versatile role, you ensure the quality and compliance of our products and processes. You take responsibility for the testing and release of products and quality-relevant documents, coordinate quality-related issues and actively participate in the continuous optimization of processes. Quality Assurance Specialist | 100% # Ref-Nr. 8064 Work location: Burgdorf Your main tasks ### • Responsible for documentary release of products (end and intermediate products) • Testing and release of manufacturing documents regarding correctness & GMP compliance including documentation in SAP as well as initiation of necessary measures in case of deviations • Testing of samples of internally manufactured individual parts, components and finished products as well as organization and administration of the retention sample warehouse, including archiving and disposal of samples and associated documents • Issuing certificates of conformity and analysis for finished products • Participation in the creation and administration of manual and automatic master certificates • Coordination of quality-relevant issues, development of proposed solutions as well as participation in the continuous optimization of processes and workflows Your profile ### • Completed vocational training in the commercial or technical field • Min. 2 years of experience in a comparable role in a regulated environment (e.g. GMP / ISO 13485), with further training in quality management • Strong communication skills, precise way of working and assertiveness • Digital affinity (MS-Office and S4/HANA user knowledge) • Willingness to work at several locations in Burgdorf as well as in Solothurn • Fluent German skills (C1) as well as basic knowledge of English (min. A2) in spoken and written form

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Posted 7 weeks ago

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