Permanent contract
Part-time 50% or full-time
Aalen, Germany
Join the tooz team
We are tooz technologies, a spin-off of ZEISS, shaping the future of smart glasses for everyday life. We are focused on development and manufacturing of next level optics, enabling eyewear that look and function like everyday glasses and augment your reality with valuable information.
To complete our team, we are looking for a Quality & Regulatory Manager (m/f/d) in part-time (50%) or full-time.
Your responsibilities
As a Quality & Regulatory Manager at tooz, you are responsible for:
- Establishing and maintaining the quality management system together with the tooz team;
- performing internal audit and management reviews;
- communicating with notified body and authorities, and managing external audit;
- following up CAPA;
- leading the transition to new standard and regulation, such as MDR;
- creating and maintaining technical documentations;
- leading CE registration and supporting product registration for other countries and regions;
- guide the R&D process from quality & regulatory compliance perspective
Requirements
- First quality and regulatory experience in production and R&D environment, preferably in the medical device industry
- Be familiar or motivated to dive in
- the requirements of ISO 13485
- in establishing and maintaining quality management system
- the requirement of EU medical device regulatory requirement
- creating and maintaining technical documentation
- Good at coordination, communication and problem solving
- Pragmatism and hands-on mentality
- Fluent spoken and written English and German
Working at tooz
Our international team is driven by the common mission to deliver exciting smart glasses solutions. At tooz, we value flexibility, reliability and a hands-on mentality. With us, you can expect not only a great team, a good working atmosphere and flat hierarchies, but also a challenging and inspiring environment to grow and develop yourself.
Join tooz and contribute to shaping the future of smart glasses!
More information
Interested? Please send your application including salary expectation range and your earliest possible starting date to job@tooztech.com.