Quality Engineer

Vor 4 Tagen


Zürich, Schweiz agap2 Switzerland Vollzeit

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from agap2 Switzerland Specialist in hiring engineers, pharmacists and business managers for Life Science in Switzerland 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. Responsibilities We 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. Qualifications Engineering degree or Master in quality, mechanical engineering, industrial engineering, or similar Minimum 3 years of experience in the Medtech industry within manufacturing and quality functions Strong knowledge of QMS principles and standards (ISO 13485, GMP) Fluent in German and English EU or Swiss citizenship Seniority Level Associate Employment Type Full‑time Job Function Engineering, Consulting, and Quality Assurance Industries Engineering Services, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at agap2 Switzerland by 2x We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr


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