Description
We are looking for a
Configuration Manager for Medical Devices (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in the Zurich region
Branch: Pharmazeutische Industrie
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Configuration engineer
Keywords: Konfigurationsingenieur