h3Design Quality Engineer /h3 pBien-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. /p pTo support our growth,we are looking to add to our team at our site in bB /b bienn /b be /ba: /p pIn 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. /p h3Your Responsibilities: /h3 ul liLead 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).br/ /li liSupport Verification Validation activities to ensure compliance with applicable Design Control requirements.br/ /li liGenerate and maintain Risk Management during NPD and Design Changes using principles from ISO 14971.br/ /li liEnsure quality assurance according to principles of Design Changes of medical devices during all stages of product development.br/ /li liUpdate existing product documentation in compliance with requirements of MDR.br/ /li liCreate, review or approve DMR and DHF documentation released during NPD and Design Changes.br/ /li liContribute to generate and maintain User Information Material.br/ /li liContribute to continuous improvement of internal procedures related to NPD, Design Change and Risk Management.br/ /li liBecome key contributor to product reprocessing methodology and testing (cleaning and sterilization).br/ /li /ul h3Your Profile: /h3 ul liAt least Bachelor’s Degree in mechanical, micro-mechanical or biomedical engineering.br/ /li li1 to 3 years’ experience into quality assurance of medical devices, ideally class lla or above.br/ /li liDemonstrated knowledge of DMR and DHF structure and contents.br/ /li liExperience with ISO 13485 QMS and with Risk Management for Medical Devices.br/ /li liExperience with EU MDR 2017/745.br/ /li liComputer skills: MS-Office suite, and ideally PLM system.br/ /li liFluent in French, with good knowledge of English (level B2 or higher).br/ /li liStrong organizational and follow-up skills, attention to detail.br/ /li liOpen-minded personality with the ability to quickly integrate a team.br/ /li /ul h3What We Also Offer : /h3 ul liA supportive and collaborative work environment within a family-oriented company structure.br/ /li liThe opportunity to join an innovative and fast-growing industrial SME.br/ /li liA role with real impact on the company’s performance and results.br/ /li liOpportunities for continuous learning and ongoing professional development.br/ /li /ul ul liRue de l'Ouest 2b 2340 Le Noirmont /li /ul #J-18808-Ljbffr
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Unsere Agentur bietet Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf über 39 Jahre Erfahrung in der Personalvermittlung zurückblickt. Mit einem starken Fokus auf die berufliche Entwicklung und ein unterstützendes Teamklima, fördern wir Ihre Fähigkeiten und bieten Ihnen Zugang zu spannenden Projekten in der Region Sottoceneri. Genießen Sie zudem attraktive Arbeitsbedingungen und die Chance, in renommierten Unternehmen tätig zu sein.
