Process Support Engineer
vor 2 Wochen
start date:
end date: one year contract, with a high chance on extension
workload: %
location: Rotkreuz (CH)
work model: Contracting
Your Responsibilities:
- Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management, Verification and Validation 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 project
- 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
- Ensure the delivery of timely and good quality documentation
Your Profile:
- University degree in Life Sciences, Natural Sciences or Engineering
- First experience and good technical understanding of product development processes within a highly regulated environment - preferred GMP regulated Diagnostics industry
- Database experience is a strong plus
- First work experience in Process Management (Risk-, Requirements-, Configuration-, Defect and/or Verification Management)
- 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
- Excellent verbal and written communication skills in English, and preferably German in addition
- Excellent communication and presentation skills
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