- Assumes accountability for the management of individual cases (Inquiries, Complaints, PRI/PSIs) according to regulatory and ISO Quality system requirements and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site trouble shooting and resolution of cases in a timely manner.
- Contributes to experimental design of investigations to ensure an efficient approach for root cause analysis.
- Ensures, by collaboration and interfacing with BA and global functions, appropriate measures from cases are derived, including, but not limited to workarounds.
- Assumes responsibility for timely communication of quality related information to the Country Organizations.
- Assumes responsibility for providing information from cases in order to update product documentation.
- Contributes to initial and continuous knowledge transfer from manufacturer, R&D or GCS for new products in the project phase to ensure availability of comprehensive system knowledge.
- Supports initiatives and measures to maintain enhanced interface with Country Organizations and regional representatives
- Supports constant evaluation of global case resolution vs. regional and local practice
- Supports creation of regular reports to document in-market product quality and performance
- Permanently optimizes processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement.
- Work experience in the area of medical technology in either 1st or 2nd level support or R&D related functions
- Knowledge of the diagnostic market
- Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)
- Intercultural skills as well as an analytical and solution-oriented way of thinking
- Strong communication skills in English (written and spoken) are essential
- Detail, technical orientation with excellent organization skills, strong problem solving, troubleshooting capabilities and negotiation attitude.
- Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).
- Computer literateness, knowledge of e-learning and multimedia technologies.
- Very good presentation and communication skills. Experience in technical writing.
- Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner.
- Strong customer and business orientation.
- Knowledge of additional languages is a plus