Quality Management Engineer (m/f/d)

We are looking for a Quality Management Engineer as a full-time position for our office in Berlin.

As a Quality Management Engineer at Mimi your tasks will be:

  • Creation and setup of a new quality management system according to ISO 13485
  • Creation, review and revision of documents for the QM system
  • Preparation of qualification and validation documentation for the qualification of new and existing process
  • Setting up, editing and documentation of standard processes, in alignment with existing agile workflows
  • Implementation and documentation of internal audits
  • Collaboration on documents for medical device approvals, change notifications and other regulatory procedures and processes

What we need from you:

  • Have experience in working with QM systems
  • Read & thoroughly understand ISO standard documents & MDD/MDR law
  • Transform law & standard requirements into actionable processes
  • Are open to work in a cross-functional startup environment with less strict processes, and can align this with the strict process requirements in QM
  • Are genuinely curious about how things work, and always look to improve quality and existing processes
  • Are fluent in English with great communication skills

It would be great if you:

  • Have experience with Atlassian JIRA & Confluence or other documentation/approval tools
  • Have experience with software processes like continuous delivery and automated testing is a big plus, but no requirement
  • Speaking german is a plus, but no requirement
  • Have a bachelors/masters degree in a related field
  • Are interested in audio, music, sound, and health topics

What you’ll get from us:

  • An open, airy work environment in Friedrichshain, Berlin
  • High degree of flexibility in organizing your work
  • Be part of a culture which nourishes personal growth as the base for company growth
  • Work together with an international and diverse team of domain experts
  • Weekly company breakfast and dinners
  • Modern working equipment plus plenty of audio perks and toys

Mimi is the world's leading company for digital hearing tests and sound personalization. The company was founded in 2014 in Berlin by Philipp Skribanowitz, Dr. Nick Clark, Pascal Werner and Dr. Henrik Matthies. The patented and internationally award-winning technology was developed and validated by a team of specialists in close cooperation with the Charité - Universitätsmedizin Berlin. The Mimi apps are medical devices in Europe (CE, class 1). With over one million hearing test app downloads from 150 countries, it creates the world’s largest database of digital hearing profiles. With Mimi Defined™, a technology for sound personalization could be developed, which - despite the imperfections of human hearing - can optimize the individual hearing experience for everyone. Our software can be integrated into any audio product, from headphones to TVs, smartphones or streaming services. Currently we’re working with Loewe, Bragi and beyerdynamic and one of Germany's largest life insurance companies BARMER.