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.