For our site in Muntelier and Yverdon-les-Bains, we are looking for a:
Quality Manager 100%
What we are looking for
* Quality Manager (Quality Management Representative) for the certified, harmonized Quality Management System (QMS) across two sites
* People management of the QA team in Muntelier and Yverdon (work at both sites)
* Overall responsibility for quality-related activities at Yverdon and Muntelier and leadership of the local QA organization
* Ensuring 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
* Leading and coordinating internal, customer, and notified body audits, including preparation, execution, and follow-up activities
* Acting as the primary contact for customers, notified bodies, authorities, and business partners on quality-related matters
* Overseeing core QA processes including complaints handling, CAPA, change management, and audit management
* Reporting on QMS performance and key quality indicators to top management and Global QA, and driving continuous improvement initiatives
* Managing QA resources, including team leadership and budget responsibility, in alignment with global and local policies
* Support in Regulatory Affairs for internal projects and customer requests
What makes you a great fit
* Technical background (ES, HES) with continuing education in quality management
* Experience in regulatory affairs is preferred
* Proven experience in quality assurance within a MedTech production
* Experience in team management
* Ongoing training in lean management
* Strong interest in and understanding of technical topics
* Confident and competent communicator, able to interact effectively with internal departments as well as with customers and suppliers
* Good knowledge of MS Office and experience with CAQ and ERP systems
* Bilingual French and German, good written and spoken English;
Why you’ll love working with us
* An open company culture, short decision-making processes, and an open-door philosophy
* 6 weeks of vacation
* Attractive social benefits
* Opportunities for individual development
* Regular team events
* Loyalty bonuses
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