Medical Device Risk & Quality Expert

bayoonet Aktiengesellschaft; Germany (OH); 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

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.