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

BAYOOMED; Berlin, Darmstadt, München; Hybrid; EUR 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Flexible hours

Company pension plan

Performance-based pay

On-site Berlin office

Zusammenfassung

BAYOOMED is seeking a Risk and Quality Management Expert to lead risk analyses and software FMEAs for medical devices in line with ISO 14971. The role interfaces with customers and development teams, ensuring MDR and ISO 13485 compliant processes and documentation.

The position supports a hybrid work model with on-site presence three days per week and two days remote, reflecting Bayoomed's collaborative culture and focus on quality and compliance.

Qualifikationen

• 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 MDR and the approval procedures in other countries (USA, Canada, etc.).
• Knowledge of the documentation requirements according to ISO 13485.
• Very good written and spoken German and English skills.

Aufgaben

• Planning and preparation of risk analyses and assessments for medical devices.
• Creation of software FMEAs.
• Responsibility for risk management in accordance with ISO 14971: recognizing hazards and assessing 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.

Kenntnisse

German language

English language

Customer orientation

Analytical thinking

Teamwork

Proactive mindset

Ausbildung

Medical technology

Computer science

Health management

Jobbeschreibung

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 when we work together as a team—that’s why we operate a hybrid model with at least three days per week on-site at the respective location and two days working flexibly from home.

• Planning and preparation of risk analyses and assessments for medical devices
• Creation of software FMEAs
• Responsibility for risk management in accordance with ISO 14971:
  • 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.

Here’s 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

Opportunities to actively contribute to exciting and challenging tasks and projects

Flexible work hours and models where no work hours are lost (lifetime work account)

Performance-based pay plus the option of a company pension plan

Locations with excellent public transportation and highway access

Flat hierarchies in cross-functional teams

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 contributions, and technical expertise of every team member, which makes all the difference.