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ISS AG, Integrated Scientific Services

Biel/Bienne

Senior Consultant Quality & Engineering Support Medical Technology

60 bis 100% 05.02.2019
Senior Consultant Quality & Engineering Support Medical Technology
ISS AG, Integrated Scientific Services, is a leading Swiss service provider for the Medical Technology industry. We are a team of more than 30 engineers, scientists and medical experts and consult and support our customers from development to international registration and launch of medical devices. We aspire and commit ourselves to professionalism, quality and use of scientific methods. To strengthen our services in the scope of quality management of our customers we are looking for a Quality enthusiast with affinity for management as Senior Consultant (60 – 100%) (M/F) Quality & Engineering Support Medical Technology Your mission - Lead of customer projects and interdisciplinary engineering projects for medical devices - Develop and deliver services in the scope of the new Medical Device Regulation - Consult customers with respect to Quality Managemen t Systems for Medical Devices o Analyze existing QMS for compliance with regulatory requirements o Develop or optimize entire QMS or specific processe s or procedures o Coach customers in the application of QMS processes o Audit and remediation support - Review or create technical documentation in accordance with regulatory requirements - Contribute to our own QMS (we are ISO 13485 certified) in close collaboration with our Regulatory Affairs, Clinical Services and Software Engineering experts If apt and interested: - Teach students in the scope of our teaching assignment (university, university of applied science) Your profile - You are convinced that sound Quality Management helps the customer on in his Business and does not constrict - You show entrepreneurial spirit and want to help shape processes, you enjoy consulting and accompanying customers in optimizing their ways of working with respect to quality and efficiency. - You like to act in a highly dynamic environment and to familiarize quickly with new situations and questions of our customers - You are a MedTech insider, experienced in MedTech q uality management in general, and you are familiar with the implementation and application of 21 CFR 8 20, EN ISO 13485:2016, EN ISO 14971:2012, IEC 62366:2015 - You contribute at least one special focus topic to the team, e.g., Software as Medical Device, medical electrical equipment, biocompatibility, sterilization process validation. You know the corresponding applicable standards, such as IEC 82304, IEC 62304, IEC 60601, ISO 10993, ISO 17664. Experience in IVD and combination products are assets. - You know the service provider business, and you are ready to go on­site for limited periods - You have passed a technical or scientific vocational training, or equivalent professional experience; basic medical knowledge is an asset. - You have very good knowledge (written and oral) of the English language, as well as either German or French. Basic knowledge in the other language is an asset. Our proposal We provide you with an interesting, versatile, and challenging task, embedded in an interdisciplinary t eam, facilitating manifold opportunities for development. You can actively participate in shaping the future of our company and develop your entrepreneurial skills. Yo u benefit from flexible work time models and training possibilities. Possible places of work are Biel (next to the main station), Geneva (Campus Biotech – EPFL Innovation Park), and on­site at customers. Home Office is an option. Application Have we made you curious? We are looking forward to your questions or your complete application docume nts sent to the email address below. Proposals of recruitment agencies are not considered. Johannes Schwarz, PhD Head Services Quality & Engineering Support Tel. 032 513 6762 johannes.schwarz@iss­ag.ch ISS AG, Integrated Scientific Services Robert­Walser­Platz 7 2503 Biel/Bienne www.iss­ag.ch

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Website http://www.iss-ag.ch

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