Quality Manager (d/f/m)

Apply Now

Job Description

  • Taking the role of Quality Management Representative (“Qualitätsmanagementbeauftragter”): You take the responsibility for the QMS including document control, creation, revision, and approval of QMS documents in compliance with regulations.
  • CAPA management: You ensure identification, recording and actions taken related to nonconformities, safeguard processing of CAPAs, and driving the execution of CAPA related tasks.
  • Internal and external audits: You organise internal and external audits and represent the company and manage all audits.
  • Training: You provide QMS trainings to our employees, and coach and support teams in the application of the QMS.
  • Management Review: You organize the management review and present parameters for evaluation of compliance and effectiveness of the QMS.
  • Support creation and review of the technical documentation according to the requirements of EU 2017/745 (MDR), non-EU country regulations, US FDA 21 CFR and medical device regulations of other regions.
  • Risk Management: You conduct the risk management for Smart Reporting products according to ISO 14971.
  • In your role, you will report directly into the C-Level.


  • You have prior experience in Quality Management for Medical Devices, have contributed or lead building/maintaining a QMS, and have actively participated in internal and external audits
  • You are familiar with ISO 13485, European Medical Device Regulation, ISO 14971, norms like ISO 62304, ISO 62366, corresponding guidance documents and their application
  • You are confident to find the right balance between building an audited QMS for Software as a Medical Device while keeping it lean for swift and agile operations
  • You feel comfortable with the coordination of processes and guiding your colleagues in the application of the QMS
  • You are business fluent in English and you have strong overall communication skills; German skills are considered a plus


  • Have an insight to all departments of a fast-growing scale up company
  • Bring in your own ideas and experience, help set up structures
  • Build a design system within an innovative product in Healthcare IT
  • Flexible working arrangements: Hybrid work (Remote/ Munich Office) and flexible working hours (part-time possible)
  • 30 days paid vacation
  • A variety of employee benefits: Workation, Company Events, Jobrad and LinkedIn Learning