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

bayoonet Aktiengesellschaft; Deutschland; On-site; USD 70,000 - 90,000; Full time

Job summary

bayoonet Aktiengesellschaft is looking for a Risk and Quality Management Expert to manage risk analyses and ensure compliance with ISO standards. The role involves interfacing with customers and development teams, along with creating and updating documentation processes.

The ideal candidate should have a degree in medical technology or a related field, with extensive experience in risk management and knowledge of regulatory procedures. Proficiency in German and English is essential.

Qualifications

• Several years of professional experience in risk management according to ISO 14971.
• Knowledge of Medical Device Regulation (MDR) and approval procedures in various countries.
• Very good written and spoken German and English skills.

Responsibilities

• Plan and prepare risk analyses for medical devices.
• Create software FMEAs.
• Act as an interface between customers and development teams.

Skills

Risk management

Regulatory knowledge

Customer orientation

German language

English language

Education

Completed studies in medical technology, computer science, or health management

Job description

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

Your profile

• 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.