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Quality Manager (f / m / d)

Quality Manager (f / m / d)

Aesculap AG – part of the B. Braun GroupFreiburg im Breisgau, DE
Vor 6 Tagen
Stellenbeschreibung

You're an important part of our future. Hopefully, we're also a part of yours! At B. Braun, we protect and improve the health of people worldwide. As a Corporate Start-Up based in Freiburg, Germany, B. Braun New Ventures takes a lead role in the digital transformation of healthcare. With a young and fast-growing team, we develop solutions to automate medical procedures across various business areas. Our goal is to augment caregivers' eyes, hands and decision making with sensors, robotics, and artificial intelligence. Our cloud platform team is focused on creating corporate-wide solutions that will drive the next generation of B. Braun's digital products and connected devices. The technologies and products we develop create new treatment possibilities, enable sharing of clinical experience, and result in better patient care.

Duties and responsibilities

  • Develop, implement, and maintain quality management system (QMS) processes in accordance with ISO 13485, IEC 62304, IEC 81001-5-1, and other relevant standards
  • Oversee the entire software development lifecycle to ensure compliance with quality, security, and further regulatory requirements
  • Support development teams in technical documentation leading up to software releases
  • Ensure security-by-design principles by integrating security risk management (ISO 81001 5-1), threat analysis, and security risk assessments into the development process
  • Provide training and guidance to teams on software development, regulatory compliance, and best practices

Professional competencies :

  • You are experienced in maintenance of an ISO 13485 compliant quality management system
  • You are familiar with applicable norms and standards for medical device software development
  • You already worked for international product approvals or with international standards and guidelines and realization of corresponding project and process requirements
  • Your knowledge of Information Security Management Systems according to ISO 27001 would be a plus

    • Personal competencies :

  • You have a sense for details, are driven to deliver and retain an overall perspective
  • You can balance well between setting high quality standards and fast execution
  • You are a self-starter, a continuous learner, and an explicit networker
  • You have an agile mindset und enjoy working in a start-up environment
  • You have excellent written and spoken English skills

    • What we offer :

    Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

    Benefits :

  • Flexible and family oriented working hours and hybrid working between office and home
  • A brand-new modern office optimized for concentration and collaboration with an integrated high-tech simulation operating room and generous social areas and creativity zones
  • High quality of life in one of Germany's most attractive cities
  • Subsidy for public transportation

    • B. Braun New Ventures GmbH | Haakon Schröder | +49 160 95704687