Risk and Quality Management Expert (m/f/d)

• Planning and preparation of risk analyses and assessments for medical devices
• Creation of software FMEAs
• Responsibility for risk management in accordance with ISO 1497:
  • Recognizing potential hazards from the medical devices and their accessories
  • Assessment and evaluation of risks
• Act as an interface between customers and our development teams
• Responsibility for creating, implementing and updating processes and documentation for the respective medical devices

• Completed studies in medical technology, computer science, health management or a comparable qualification
• Several years of professional experience in risk management according to ISO 14971
• Comprehensive knowledge of the Medical Device Regulation (MDR) and the approval procedures in other countries (USA, Canada, etc.)
• The ability to quickly familiarize yourself with new technical and specialist topics
• Strong customer orientation and diligence
• Proactive, independent and solution-oriented way of working
• Knowledge of the documentation requirements according to ISO 13485
• Very good written and spoken German and English skills

In addition to your technical and professional expertise, you are characterized by your social skills. You are reliable, committed and flexible. You are able to actively listen and analyze customer requirements in a well-founded manner and have a high degree of independence as well as a strong ability to work in a team. Above all, you are a thinker.