Quality Manager (f/m/d)

  • Berlin

Nia Health

What’s in it for you:

  • You will have a massive impact on the growth of our venture from the scratch and therefore its ultimate success at scale — super steep learning curve!
  • You will enjoy full independence and ownership
  • flexible working hours & home-office possible

Education:

  • Bachelor or master in computer science, engineering, mathematics or physics
  • Academic degree issued after November 2014

Experiences & Skills:

  • 2+ years of quality management in medical device development
  • Experience with medical software with risk level I and IIa
  • Audits according to ISO 9001 or preferable ISO 13485
  • Regulatory requirements for compliance with MDD
  • Regulatory modifications for compliance with upcoming MDR
  • Relevant norms: IEC 62304, DIN EN ISO 14971, DIN EN ISO 13485
  • Establishing and maintaining quality management system
  • Usage of tools jira and confluence
  • Languages: English (fluent), German (optional)

Tasks:

  • Building up quality management system according to ISO 13485
  • Driving medical software certification process (MDR, IIa)
  • Support process specification and establishment within company
  • Communication to LAGeSo and notified body
  • Perform internal audits and conduct external audits

It’s our mission to bring digital companionship for patients with chronic diseases to the next level using mobile technology combined with machine learning. We want to empower patients to take back control of their life and shape their own health. By full integration into the treatment process through daily interactions & AI-based recommendations our users lead better lives.

Interested? Then we are looking forward to your application. Please send your CV with salary requirements and possible starting date.

Um sich für diesen Job zu bewerben, senden Sie Ihre Unterlagen per E-Mail an jobs@nia-health.de

Digitale Helferin