Ph3Overview /h3 pbJob Category: /b Quality Environment /p pbJob Type: /b Full Time /p pbJob Location: /b Muntelier Yverdon-les-Bains /p pbCountry: /b Switzerland /p pElos Medtech is one of the world’s leading development and manufacturing partners for companies in the medical technology sector. With sites in Switzerland, Sweden, Denmark, Germany, China, and the United States, we specialize in the production of implants, instruments, and components for medical technologies. /p pWe are looking for individuals who share our values — passion, trust, and results — so we can grow together and achieve even greater success. If you are ready to give your best and join an environment that values collaboration and commitment, we look forward to receiving your application. /p pFor our site in Muntelier and Yverdon-les-Bains, we are looking for a: /p pbQuality Manager 80 – 100% /b /p h3What We Are Looking For /h3 ul liQuality Manager (Quality Management Representative) for the certified, harmonized Quality Management System (QMS) across two sites /li liPeople management of the QA team in Muntelier and Yverdon (work at both sites) /li liOverall responsibility for quality-related activities at Yverdon and Muntelier and leadership of the local QA organization /li liEnsuring the implementation, maintenance, and continuous improvement of the QMS in compliance with ISO 13485, FDA 21 CFR Part 820 and applicable national and international regulations /li liLeading and coordinating internal, customer, and notified body audits, including preparation, execution, and follow-up activities /li liActing as the primary contact for customers, notified bodies, authorities, and business partners on quality-related matters /li liOverseeing core QA processes including complaints handling, CAPA, change management, and audit management /li liReporting on QMS performance and key quality indicators to top management and Global QA, and driving continuous improvement initiatives /li liManaging QA resources, including team leadership and budget responsibility, in alignment with global and local policies /li liSupport in Regulatory Affairs for internal projects and customer requests /li /ul h3What Makes You a Great Fit /h3 ul liTechnical background (ES, HES) with continuing education in quality management /li liExperience in regulatory affairs is preferred /li liProven experience in quality assurance within a MedTech production /li liExperience in team management /li liOngoing training in lean management /li liStrong interest in and understanding of technical topics /li liConfident and competent communicator, able to interact effectively with internal departments as well as with customers and suppliers /li liGood knowledge of MS Office and experience with CAQ and ERP systems /li liNative French or German speaker, with very good command of the other language as well as English, both written and spoken. /li /ul h3Why You’ll Love Working With Us /h3 ul liAn open company culture, short decision-making processes, and an open-door philosophy /li li6 weeks of vacation /li liAttractive social benefits /li liOpportunities for individual development /li liRegular team events /li liLoyalty bonuses /li /ul /p #J-18808-Ljbffr