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Quality Manager (d/f/m)

smartreporting · 30+ days ago
Negotiable
Full-time
Remote
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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

Last updated on Aug 8, 2024

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