Risk Manager.
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.
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