* Engineering - Quality Management * Life Sciences - Engineering * Zug * Contracting * Vollzeit * Immediately - 1 year * IVDR Contract duration: 1 year Location: Rotkreuz Responsibilities: * Responsible for process guidance, process optimization and documentation of various development projects (systems and assays) regarding Requirements- and Risk-Management, Configuration Management, Verification and Validation Management, defects management and/or Usability Engineering * Support translation of multi-level requirements via Requirements Management process * Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representatives * Ensure all risks and requirements are maintained within a database and streamline approach across projects * Ensure the delivery of timely and good quality risk and requirements documentation * Establish and perform Configuration Management in complex development projects * Support development projects as Verification Manager (Planning, Guiding, Training, Reporting) * Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments. * Information gathering from respective stakeholders including consolidation of information * Independent execution of work packages within area of responsibility * Organize and manage their own time within scope of assigned work packages * Ensure the delivery of timely and good quality documentation Requirements: * University degree in Life Sciences, Natural Sciences or Engineering * Good technical understanding of development processes * Excellent verbal and written communication skills in English and preferably German in addition * Database experience preferred * Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing is a plus * First experience in product development in a highly regulated environment is preferred (n2H) * Experience in the Diagnostics industry and experience within the GMP regulated environment is a plus * Ability to lead by influence, demonstrated effectiveness, drive decisions and account for results; ability to resolve conflicts and adapt to change, effective to drive results and achieve project goals