Process Manager/IVD Design Control Excellence (m/f/d)

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