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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