Risk Management Specialist
vor 3 Wochen
Main Responsibilities
- Ensure the company's products meet the latest risk management standards, adhering to ISO 14971, ISO 13485, and ISO 62304 during development and lifecycle.
- Represent risk management in audits conducted by regulatory bodies, customers, and internal teams.
- Collaborate with cross-functional teams to ensure effective communication and information flow among project stakeholders.
- Support project and product management in implementing risk control measures.
- Contribute to the continuous improvement of risk management processes within the company.
- Utilize software tools for risk analysis, including FMEA and FA.
About You
- Bachelor's degree or higher in Engineering or Science.
- Minimum 2 years of experience in Design and Development, preferably in product risk management of medical devices 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 and a team-oriented personality.
Working at Ypsomed
- Pension fund with company contributions.
- Flexibility in working hours, including shiftwork and part-time options.
- Opportunity to work in a dynamic and growing company.
- Chance to contribute to the development of innovative medical devices.
About Ypsomed
Ypsomed is a leading company in the development and production of injection and infusion systems for self-medication. Our team of over 2,000 employees worldwide works together to make a positive impact on people's lives.
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