Quality Assurance Manager

Want to make a real impact? At Etac, we create solutions that improve quality of life. We are looking for a **Quality Manager** for Mobility, Power Assist– a key role that combines regulatory responsibility with a strong technical focus. This is an opportunity to influence product development and operational excellence while ensuring compliance with international standards. You will play a central role in shaping quality structures and supporting Etac’s ambitious global growth journey. **Your key responsibilities** - Ensure regulatory compliance for our brand Klaxon medical devices through collaboration with R&D and supply chain teams. - Drive Quality & Regulatory initiatives and processes aligned with the business priorities, applying a strong technical focus to support product development and operational excellence. - Maintain and enhance Quality Management System (QMS) infrastructure and ensure adherence to ISO 13485, MDR and FDA requirements. - Support continuous improvement initiatives and risk management processes with a hands-on technical approach. - Interact with Regulatory Authorities (e.g., FDA, EMA, BASG) - Perform statistical analysis, trending, and reporting of customer complaints, NCRs, and CAPAs. - Establish and maintain internal audit schedules and conduct audits. You will work closely with R&D, Supply Chain, and other functional teams, as well as Etac Group´s Quality & Regulatory teams in Denmark, Sweden, Poland and the USA. In this role, you will report to the Managing Director of Klaxon and have a reporting dotted-line to the VP Quality & Regulatory. You will lead a small team, including one direct report (Quality Engineer), and be an active member of the local management team in Austria. **Your profile** - Degree in Engineering or equivalent technical background. - Minimum 5 years of technical experience in the medical device industry or a complex technical industry (e.g., automotive). - Familiarity with standards such as ISO 13485, knowledge of MDR and FDA is a plus. - Knowledge of QMS and auditing processes is an advantage. - Strong communication skills in English; Italian is a plus. You are a proactive team player who builds strong cross-functional relationships to drive innovation while ensuring compliance. You take initiative to integrate quality and regulatory requirements early in product development, helping reduce risks and accelerate progress. With a hands-on approach and strategic mindset, you balance big-picture thinking with attention to detail. Your analytical skills and integrity ensure robust processes, while your excellent communication and influencing abilities make you effective in engaging stakeholders across the organization. **Why Etac?** We are a dynamic company on an exciting journey, with job opportunities in several career fields and many parts of the world. As part of our team, you will work in a place that values: - Working with something that helps people - Possibilities to grow within one's role and the organisation - Good work-life balance - Freedom with responsibility **Interested?** Submit your CV in English by 31st of January 2026 at the latest. We are looking forward to reading your application. Quelle: https://indeed.com/viewjob?jk=a9be4c8e308d03f4

Level: senior