Quality Manager (d/f/m)

Quality Management:

• Act as Quality Management Representative (“Qualitätsmanagementbeauftragter”), overseeing QMS document control, creation, revision, and approval

• Manage CAPA processes, ensuring nonconformities are identified and addressed

• Organize and manage internal and external audits
• Provide QMS training and support to employees
• Conduct management reviews, presenting QMS compliance and effectiveness
• Guide teams on QMS processes
• Create and review technical documentation per EU 2017/745 (MDR), non-EU country regulations, US FDA 21 CFR and medical device regulations of other regions
• Conduct risk management for Smart Reporting products according to ISO 14971
• You will report directly into the C-Level

Requirements

• You have profound experience in Quality Management for Medical Devices and you have contributed or lead building/maintaining a QMS, and have actively participated in internal and external audits
• Familiarity 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 and ISMS
• You are business fluent in German and English and you have strong overall communication skills

Benefits

• The opportunity to contribute to a cutting-edge medical software product with rapid growth and significant funding from top-tier investors and EU grants
• Working for a meaningful product that positively impacts healthcare and people's lives
• Joining a positive, highly skilled, and international team
• LinkedIn Learning licenses and individual development budget to support your professional growth
• Regular Company Events, Jobticket, Jobrad, and further Benefits
• Part-time eligible, flexible working hours and up to 100% Remote work possible
• Competitive compensation
• 30 days paid vacation