Technical Assistant and Complaint Investigator (m/f/d) ICD/Blood Laboratory, temporary for 2 years

As a Technical Assistant and Complaint Investigator (m/f/d) ICD/Blood Laboratory, you will be responsible for carrying out tests for the verification and validation with human blood of devices and disposables of the DesignCenter at the Friedberg site as well as for various research facilities of the R&D Friedberg and Mirandola (Italy).

In this role, you will be responsible for carrying out tests on all transfusion-medically relevant disposables of various devices, including the corresponding documentation in various systems as part of the complaints management of the Investigation Center Disposables at the Friedberg site.

Your tasks:

• Quality control:

Implementation of internal and external quality controls in the blood laboratory in compliance with ISO and GLP standards

• Test development and execution:

Performing tests and developing test methods in the areas of autotransfusion, cell therapy and plasma donation with human blood

• Complaint management:

Recording of complaints via SAP, processing of complaint samples in the areas of transfusion medicine and cell therapy, investigation and evaluation of the cause of errors, creation of English complaint documentation and review of previously created complaint reports in the SAP-P94 system as well as statistical evaluation of complaint figures and creation of presentations for complaint processing

• R&D support:

Taking over all necessary laboratory work, measurements, analytics and quality controls for R&D projects, assisting in the creation of laboratory WIs and SOPs as well as assisting in the validation, verification and testing of R&D medical products/devices

• Induction and training:

Induction and training of new employees while adhering to the required WIs and SOPs according to the training plan

• Equipment care and laboratory organization:

Care and maintenance of equipment according to WIs/SOPs and organization of storage rooms for consumables

Your profile:

• Completed studies or training in the medical or biological field

• Several years of professional experience in the field of technical assistance (m/f/d) (in various areas) or comparable, preferably in transfusion technology

• Experience in complaints processing, preferably in the field of medical devices

• Knowledge and experience in the field of medical device documentation is an advantage

• Good knowledge of the GLP environment

• Good knowledge of SAP and MS Office

• Fluency in English (written and spoken), knowledge of French is an advantage

The position is temporary as a parental leave replacement for 2 years.