Quality Engineer

Agap2 is an European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.ResponsibilitiesWe are looking for an engineer who will take responsibility for quality performance and regulatory compliance in Medtech manufacturing environments:Ensure operational quality assurance on the production floor, including management of deviations, CAPA, root cause analysis and troubleshooting activities.Evaluate and monitor supplier performance, lead audits, support inspections, manage quality agreements, and ensure raw materials and components meet required standards.Oversee quality management system (QMS) activities, including procedure development, continuous improvement, KPI monitoring, and alignment with regulatory expectations (ISO 13485, GMP, etc.).Lead risk management activities across manufacturing operations and propose pragmatic, efficient solutions to secure product quality and patient safety.Act as a trusted quality partner from routine production support through scale-up, industrialization and lifecycle management of products.QualificationsEngineering degree or Master in quality, mechanical engineering, industrial engineering, or similarMinimum 3 years of experience in the Medtech industry within manufacturing and quality functionsStrong knowledge of QMS principles and standards (ISO 13485, GMP)Fluent in German and EnglishEU or Swiss citizenship