This role is all about supporting product performance monitoring and vigilance activities related to products manufactured and distributed in compliance with the Austrian Medical Device Law as well as worldwide applicable regulatory and guidelines and corporate requirements. The position includes responsibility for related quality system processes, supporting their monitoring, maintenance and improvement.
Performing incident reporting and other vigilance activities in compliance with applicable regulations and corporate requirements.
- Monitoring performance of marketed MED-EL medical device products including quality data trending, risk management and product reliability analysis.
- Investigation, evaluating and following up on incidents of special note.
- Technical education (at least bachelor degree) in Medical Devices, Biomedical Engineering or similar
- 2 years working experience with Medical Device manufacturer quality systems and pertaining regulations, preferably for Class III devices (strongly preferred).
- Aptitude to learn and receive training as required, especially related to technical knowledge of local quality system processes, products and the related regulations environment.
- Familiarity with related medical aspects and awareness of clinical device use will be beneficial.
- Knowledge of statistical techniques, product / process quality metrics is preferred.
- Very good knowledge of English and with German preferred
- Motivated and flexible
- Team player
For more information on this vacacny or any QA related positions, Europe wide, please do not hesitate to contact the senior Consultant Andrew Boroky on 0044 (0) 207 940 2116 or send your application to firstname.lastname@example.org. I look forward to receiving your application!
Posted: 30/07/2012 | NPJ Ref: 84523