Engineer / Process Supporter

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

For our client Roche Diagnostics in Rotkreuz, we are looking for a motivated and reliable (m/f/d)

Engineer / Process Supporter 100%

• Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management and/or Verification & Validation Management
• 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 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 
• First experience and good technical understanding of product development processes within a highly regulated environment 
• Database experience preferred 
• Experience in Process Management (Risk-, Requirements-, Configuration-, Defect and/or Verification Management) is a plus 
• Experience in the Diagnostics industry and experience within the GMP regulated environment is a plus 
• 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
• 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
• Excellent verbal and written communication skills in English, and preferably German in addition
• Excellent communication and presentation skills / Open minded team-player