Background:
Daily tasks tasks will be the
* Monitoring and ensuring compliance with regulatory requirements (ISO 13485, 21 CFR Part 820) and internal processes in the product development process
* Support the development of interdisciplinary teams in the statistical design of experiments and the technical documentation
* FMEA moderation and support the project manager for risk management activities in accordance with ISO 14971
* Conducting audits
As such, we seek a degree qualified QA Professional with a number of years experience in the Medical Devices industry (including a working knowledge of the MDD and IVD, ISO 13485 and 21 CFR 820), experience in the implementation of regulatory requirements in the product development environment, experience in the application of statistical methods for experimental design, and a good command of English and German.
This company is committed to Quality, and with significant growth plans for the next couple of years, hence a great time to join.
For more information on this vacancy, or any other medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at a.boroky@nonstop-devices.com