Job Description

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.
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

Sounds like a great job?
Then we look forward to receiving your complete application documents through our online application form.
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Find more vacancies at:
Job Profil

• Engineering - Quality Management
• Life Sciences - Engineering
• Zug
• Contracting
• Vollzeit
• Immediately - 1 year
• IVDR

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Agnieszka Kawalec
Talent Acquisition Consultant
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