Configuration Manager for Medical Devices (m/f)

REFERENZNUMMER:

262767/4

IHRE AUFGABEN:

-Support a diagnostic instrument development project consisting of more than 100 team members
-Responsible for standard activities of configuration management for the instrument according to ISO 10007
-Responsible for the elaboration and enforcement of the configuration management process plan within the assigned project
-Responsible for cross-functional alignment of the configuration baselines together with the project management
-Driving the selection of configuration items cross-functionally within the assigned project
-Responsible for the elaboration of a configuration item tree
-Pro-active collection, provision and reporting of the relevant configuration information
-Responsible for the release and communication of configuration baselines
-Responsible for ensuring the controlled change process for configuration items
-Responsible for the regular status reporting of configuration records (configuration information, release notes etc.)
-Verification of correctness of information within the records of the configuration management

IHRE QUALIFIKATIONEN:

-Degree in a relevant engineering discipline, e.g. mechatronics, technical informatics or related field (advanced degree preferred), and strong affinity to hard- and software
-Experience in configuration management in complex medical leadership skills to lead the hardware & software configuration managers
-Experience in device development projects (hardware, software), preferably in the diagnostic industry
-Experience in working in a regulated environment (e.g. FDA, ISO 13485 etc.)
-Ability to work in an interdisciplinary environment and manage technical interfaces pro-actively
-Power of persuasion and solid communication skills - ability to clearly convey the benefit of configuration management
-Ability to work independently as well as in a team, especially in a team with indirect reporting relationships
-Strong data processing skills with advanced competence in excel, SAP and/or other Enterprise-Resource-Planning systems
-Ideally CM II professional skills
-German and English language skills are necessary

WEITERE QUALIFIKATIONEN:

Configuration engineer