Descripción
--- base: / meta-keywords: meta-viewport: width=device-width, initial-scale=1.0 title: Design Quality Engineer --- Design Quality Engineer ======================= Bien\-Air Surgery is a growing international company which develops, manufactures and markets high\-tech instruments for microsurgery. We have held an enviable position in the international market for many years thanks to our emphasis on invention and innovation, and the high quality of our products and services. To support our growth,we are looking to add to our team at our site in **B** **ienn** **e** a: Design Quality Engineer ======================= In this role, you will play a key part in a fast\-moving team and participate in the development of our Medical Devices. You will work closely with different departments to ensure the design quality of the final product. ### Your Responsibilities: * Lead and support New Product Development (NPD) and Design Changes by ensuring compliance of activities and documentation to internal QMS requirements as well as to external regulations and standards (FDA, ISO). * Support Verification \& Validation activities to ensure compliance with applicable Design Control requirements. * Generate and maintain Risk Management during NPD and Design Changes using principles from ISO 14971\. * Ensure quality assurance according to principles of Design Changes of medical devices during all stages of product development. * Update existing product documentation in compliance with requirements of MDR. * Create, review or approve DMR and DHF documentation released during NPD and Design Changes. * Contribute to generate and maintain User Information Material. * Contribute to continuous improvement of internal procedures related to NPD, Design Change and Risk Management. * Become key contributor to product reprocessing methodology and testing (cleaning and sterilization). ### **Your Profile:** * At least Bachelor’s Degree in mechanical, micro\-mechanical or biomedical engineering. * 1