Ihre Aufgaben
The working student (m/w/d) – Risk management shall assist in the maintenance of Risk Management File (RMF) of all Dornier products in compliance with ISO 14971.
1. Maintain Risk management files
* Update Risk management plans, Analyses and reports of Dornier sustenance products to comply with state of the standards
* Perform strategic impact assessments as part of issue and change process
* Establish traceability of defined control measures
1. Assist in new product developments
* Support in initial setting up of Risk analysis for new development projects through pro-active co-ordination with stakeholders
* Perform traceability checks to make sure defined risk control measures are adequately addressed in requirements and verified
1. Assist in usability engineering
* Assist in performing user-related risk analysis as part of usability engineering file
* Create Known Use Problem Analysis
* Assist in updation/ creation of usability protocols and reports
Ihr Profil
* ongoing technical university studies, preferable in medical technology or in a related field
* interest in regulatory topics in the field of medical device technology and motivation to familiarize yourself with standards, guidelines, and quality requirements. Prior knowledge is desirable but not essential
* Analytical and strategic thinking
* Assertiveness
* Good interpersonal skills
* Problem-solving skills
* Knowledge of MS office
* Fluency in English, Knowledge in German is an advantage
Warum wir?
* Personal induction plan and comprehensive onboarding
* Flexible working hours
* interesting tasks in a dynamic, international environment
* Continuous training and development
* Flat hierarchies
* Attractive canteen
* Free coffee, tea and water
* Employee events
* Charging stations for electric cars
* Free language courses
Über uns
Dornier MedTech ist ein Unternehmen für Medizinprodukte mit Hauptsitz in der Nähe von München, Deutschland, und eine hundertprozentige Tochtergesellschaft von Advanced MedTech. Als Pionier auf dem Gebiet der Urologie ist Dornier einer der vertrauenswürdigsten Namen in der Branche.