Risk Management Specialist

vor 2 Monaten


Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

About the Role

We are seeking a highly skilled Risk Manager to join our team at Ypsomed. As a Risk Manager, you will play a critical role in ensuring that our products comply with the latest standards in risk management.

Key Responsibilities

  • Develop and implement risk management strategies to ensure compliance with ISO, ISO, and Part standards
  • Represent risk management in audits conducted by Notified Bodies, Competent Authorities, and pharma-customers
  • Collaborate with cross-functional teams to ensure effective communication and information flow among project stakeholders
  • Assist project and product management teams 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

Requirements

  • 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
  • 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

About Ypsomed

Ypsomed is a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. We develop and produce injection and infusion systems for self-medication with the Ypsomed Group. Our market-leading products and solutions enable people all over the globe to self-treat chronic diseases such as diabetes, obesity, or certain types of cancer, providing them with the greatest possible quality of life.



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