Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
My client is a Medical Devices developer and manufacturer
Currently I am looking for a freelancer who is available for a max of 1,5 days a week to help my client with a product validation plan and quality assurance related issues. Because the product has to be ISO13485 and FDA compliant, the Quality Assurance Engineer has to have a Medical Devices background. The quality engineer (for medical device projects) supports the project manager in assuring that products are developed in accordance with the requirements of applicable standards.
Creating and getting approval of the project verification plan will be your responsibility. You will be assisting in quality documentation (procedures/work instructions). You will assist and support in establishing a structure for the project documentation and configuration management. You will be the anchor for questions in the field of Quality Assurance. You will translate the regulations to understandable and practical language for the teammembers. You will be responsible for teammeetings to measure the progress of the development of the new device.
3 to 5 years experience
Knowledge of FDA and ISO/MDD regulations
Knowledge of change control
Knowledge of design control medical devices
Experience with working in multi disciplinair teams
Knowledge of IEC62366/IEC62304
Flexible in achieving goals
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