Verification Engineer / Technician Device Development (m/f)

REFERENZNUMMER:

287263/11

IHRE AUFGABEN:

-Evaluation, characterization and verification of medical devices for combination products
-Development of new test methods and support regarding technology transfer into commercial facilities/packaging centres (specification/method/equipment transfer)
-Implementation and qualification/validation of new lab testing equipment
-Generation of plans, protocols and reports as required in GMP facilities
-Provide technical support for key customers (packaging, quality, regulatory, process and formulation development, supply chain)
-Organise experimental, development, verification, complaint investigation and change evaluation testing

IHRE QUALIFIKATIONEN:

-Technical education, preferably with an engineering degree
-Track record and experience in practical testing and characterization of medical devices
-Experience of working in pharma or other highly-regulated environment under cGxP, QSR or similar working practices with excellent documentation skills (cGxP requirements)
-Sound knowledge of regulation, industry standards and guidance of combination products and medical devices
-Demonstrable practical knowledge regarding functional testing and reliability, instrument calibration, equipment qualification; transport studies and validation and secondary packaging is beneficial
-Basic experience in statistical techniques and risk assessment
-Excellent command of German and English in both verbal and written form
-Excellent IT knowledge

WEITERE QUALIFIKATIONEN:

Quality manager, R&D scientist