Medical Device Risk & Quality Expert

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

You will be responsible for risk analyses and software FMEAs for medical devices in accordance with ISO 14971, act as an interface between customers and development teams and ensure standard-compliant processes and documentation in accordance with MDR and ISO 13485.

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

We are strongest together as a team – that’s why we work in a hybrid model with at least three days a week on site at the respective location and two days flexibly remotely.

• 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.

What you can expect

Diverse teams of co-thinkers and customers who work together collaboratively and as equals

A positive error culture – we celebrate successes and continuously improve our collaboration

BAYOONIVERSITY for experience exchange, training, tech talks and company events

Growing vacation quota with company affiliation

Bright offices, themed meeting rooms, fresh fruit, coffee and cold drinks

Active participation opportunities in exciting and challenging tasks and projects

Flexible working hours and models where no working hours are forfeited (lifetime working time account)

Performance-related pay plus the option of a company pension scheme

Locations with excellent public transport and highway connections

Flat hierarchies in cross-functional teams

Thinkers wanted

About Us

The BAYOONET Group, with locations in Darmstadt, Berlin, Munich, Cologne, Ludwigsburg, Höhn, Basel and Mannheim, has been designing customized software and hardware in a wide range of variants for over 25 years. We are one of the top IT companies in Germany and consist of:

Each of our projects incorporates the ideas, visions, creative achievements and professional expertise of every single contributor, which makes all the difference.