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Risk Manager.

Risk Manager.

YpsomedBurgdorf, Switzerland
Vor 30+ Tagen
Stellenbeschreibung

Your main tasks

  • Ensure that our products comply with the latest standards in risk management, specifically observing ISO , ISO , and Part during product development and lifecycle
  • Represent risk management in audits conducted by Notified Bodies, Competent Authorities, and pharma-customers
  • Collaborate with various teams, including development, usability engineering, and production, acting as a service provider and partner to ensure effective communication and information flow among project stakeholders
  • Assist project and product management teams, such as testing, to ensure the successful implementation of risk control measures
  • Contribute to the continuous improvement of risk management processes within the organization
  • Utilize software tools for risk analysis, including FMEA and FA work

Your profile

  • Bachelor’s degree or higher in Engineering or Science
  • Minimum of 2 years of working experience in Design and Development (D&D), ideally in product risk management of medical or IVD devices (preferably active medical devices or combination products) or other GMP-regulated areas
  • Expertise in software risk management and service security is advantageous
  • Familiarity with software tools for risk analysis (FMEA, FA) is beneficial
  • Proficiency in German (B2 level) and English (for documentation purposes)
  • Strong communication capabilities are essential
  • A team-oriented personality and a strong team player mindset

    • Your benefits

    Pension fund

    Ypsomed covers % of the pension contributions

    Mobility support

    Charging stations, Swiss Half Fare Card, parking, close to public transport

    Free sport facilities

    Affordable or free gyms all over Switzerland

    Family friendly

    Financial contributions to childcare

    Working hours

    Shiftwork, annual working hours, part-time

    FlexWork

    Work where and when you want (in Switzerland)

    Up-to-date work environment

    Up-to-date production, offices, break areas Your Ypsomed work environment

    Ypsomed - making the treatment of chronic diseases possible

    More than 2, employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.