We are 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.
The Perfect Candidate has a university degree in Life Sciences, Natural Sciences or Engineering as well as first experience and good technical understanding of product development processes within a highly regulated environment (working experience or internship). Database experience and experience in Process Management is of advantage. Experience in the Diagnostics industry and experience within the GMP regulated environment is mandatory.
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
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