Quality Manager (m/f/d) ISO EN 13485

Full timefull-time, München/Munich
Temedica https://temedica.com/en/
Being part of Temedica means you are part of something that helps people! It means you get the opportunity to craft the future of personal health and at the same time: your own future! We strive to improve patients' Quality of Life and accompany them along their individual therapy journey - by providing health companions that are fully tailored to every patient's personal needs. At Temedica, we combine digital technologies with medical science - two areas that for us are inseparable. We believe in people like you - ambitious, open-minded, and eager to change an industry which is just at the beginning of essential changes. Join us on our journey and become part of our team in the heart of Munich!

As Quality Manager at Temedica you redefine the rules of daily collaboration and combine agile product development with a regulated Medical Device environment.

What you will be doing

  • You prepare and take responsibility for the organizational and procedural structure of the organization within a Quality Management System according to ISO EN 13485
  • You ensure regular and target group-specific trainings to build awareness for quality in our daily business
  • You perform internal audits in order to identify potential for improvements together with your colleagues and use it in the future
  • You represent Temedica and our Quality Management system during external audits and certifications
  • You collect quality data and trends for processes and products to inform the management regularly and contribute to management decision-making
  • You perform corrective and preventive actions across all Temedica teams to continuously reduce any risks for our end users

What you will bring to the table

  • You hold at least a Bachelor degree in the field of Engineering or comparable work experience
  • You have 5+ years of professional work experience in the areas of Quality Management or regulatory affairs
  • You have fundamental knowledge and a deep understanding of Quality Management systems compliant with FDA 21 CFR 820 and ISO EN 13485
  • You are well familiar with software development processes
  • You recognize problems, can clearly define, analyze and evaluate them, independently develop solution-oriented decision templates, and bring them to implementation
  • You are a communicative person, a good listener, you challenge thinks, and understand organizational interconnections and their influence
  • You have very good English language skills, both oral and written

Don't apply if

  • If you think that agile software development and ISO standards are not compatible and always one party has to step back
  • If it makes you nervous to find solutions for questions you have never seen before

What we offer you

Aside from the people, the role, our culture, and our mission, we have countless other things, that make Temedica a pretty great place to work at:
  • We are an open-minded and international team that loves to collaborate to reach our goals
  • We live a professional feedback culture with regular objective performance reviews and room to grow
  • We invest in your personal and professional growth: let's define together your goals and find trainings that fit into your personal development plan
  • We equip you with state-of-the-art technology (e.g. MacBook Pro) and offer you a workplace where you feel comfortable - right in the city center of Munich
  • We give you the chance to play a decisive role in shaping Temedica and have a direct impact on the health of thousands of patients
  • We enjoy spending quality time together such as Go Kart, Octoberfest or sports activities
  • We are a market-proven, well-funded and fast-growing company
  • We offer you relocation and visa support
Are you looking for an exciting challenge? Come and join - we are looking forward to receiving your application!
In addition to your CV, please don't forget to tell us a bit about why you are interested in joining Temedica and how an ideal role for you should look. Thank you!
Paul-Heyse-Str. 27 Munich 80336 Bayern DE Date Posted:

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Benefits at Temedica


We believe in you. That's why we give you maximum responsibility and trust from day one.


We think it is essential to engage in lively dialog and give feedback based on a culture of fairness.


We work determinedly toward achieving our goals, and we embody our common values.


Team Events

Here you“ll get fantastic coffee, snacks and, of course, a great place to work.