As Design Quality Assurance Engineer, you will ensure compliance of R&D processes, deliverables and documents to regulations, standards and good development practices.Your tasksBe part of new product development and post-market engineering activities ensuring that quality assurance requirements are met.Perform required Risk Management activities for Software and HardwareEnsure the consistency of the technical file documentationSupporting the project teams to ensure that the products in the pipeline are launched according to planProactively interact with stakeholdersSupport FMEAsSupport process improvementsSupport with open NCs and CAPA's, as requiredSupport the internal Audit program as requiredYour profileDiploma/degree in Electronics, Software and/or Mechanical Engineering or equivalent technical fieldAt least 3 years of practical experience working in a quality related role or equivalent, preferably in Medical DevicesBasic experience in Design Control and Product Risk Management for Medical DevicesKnowledge of ISO 13485, ISO 14971Ability to understand, interpret and explain device quality regulations to non-quality expertsWell organized and reliable with right level of attention of detailsExcellent interpersonal, communication and stakeholder management skillsGood English skills both written and spokenGood MS Office application skillsOur offerWe can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles. Employment level: 100%.Marcel Huber, Manager Talent Acquisition, is looking forward to receiving your complete application (cover letter, CV, references and certificates) via our online job application platform.For this vacancy only direct applications will be considered