QA Specialist

You plan, manage, and oversee qualification and validation activities for equipment and computer-based systems You create, review, and maintain qualification and CSV documentation You support and advise related departments—particularly Production, Production Support, Development, and IT—on all CSV-related matters You act as the interface between the Qualification, CSV, and IT teams You contribute to digitalization projects in the production environment You perform QA approvals for maintenance and calibration activities on equipment, utility systems, and relevant systems You ensure compliance with regulatory requirements (e.g., ISO 13485, MDR, 21 CFR Part 11) Your profile You have a degree in a technical or scientific field (e.g., medical technology, pharmaceutical engineering, information technology, industrial engineering) or a comparable qualification You have in-depth knowledge of computer system validation (CSV) and a solid understanding of regulatory requirements (ISO 13485, MDR, 21 CFR Part 11, and GAMP 5) Ideally, you have experience in the qualification of systems/equipment You have an affinity for IT, software, or digitalization topics and are interested in digitalization projects in production. You are a strong communicator and enjoy serving as an interface between QA, production, and IT You are proficient in MS Office and are willing to learn new software systems BeClub Both our Hechingen and Frauenfeld sites have a BeClub—a summer beach club where teams relax and enjoy evenings together. For Bentley members only—when will you join us? BeTasty Whether it’s breakfast, a coffee break, or a quick snack between meetings – our cafeteria has everything you need to recharge. And of course, you’ll also find a freshly prepared lunch every day – tasty, varied, and at a price that feels just right! #J-18808-Ljbffr