For our client, Roche Diagnostics, the global market leader in in‑vitro diagnostics based in Rotkreuz (ZG), we are looking for a motivated individual with initial experience and a solid technical understanding of product development processes within a highly regulated environment
Process Manager (a) The Department Design Control Excellence CH is looking for a process manager with a good understanding of IVD product development processes. The process manager is responsible for process guidance, process optimization and documentation of various development projects.
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
University degree in Life Sciences, Natural Sciences or Engineering
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
Experience in the Diagnostics industry and experience within the GMP regulated environment
Database experience preferred
Excellent verbal and written communication skills in English, and preferably German in addition
Good analytical thinking, a structured, reliable working manner, ability to prioritize, plan and manage multiple tasks and to instill a sense of urgency in teams
Good technical understanding of development processes
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
Your application Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Nazim Sagkol (B. Eng.), (+41 76 349 85 07)
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