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RORoche Diagnostics Int. AG

Senior Engineer - Design Control Excellence(m/w/x)

Risch-Rotkreuz
Full-timeOn-siteSenior

Guiding and optimizing process, system, software, and assay projects in healthcare. Two years of process management experience required. Hybrid work, 4-week workation option.

Requirements

  • University degree in Life Sciences, Natural Sciences, or Engineering
  • At least two years of Process Management experience
  • Proven experience in Risk Management
  • Proven experience in Requirements Management
  • Proven experience in Defect Management
  • Proven experience in Configuration Management
  • Preference for candidates from Diagnostics industry
  • Strong analytical thinking
  • Ability to lead by influence
  • Ability to drive decisions
  • Ability to resolve conflicts
  • Ability to instill urgency in teams
  • Excellent presentation skills in English
  • Excellent communication skills in English
  • Proficiency in German
  • Database experience
  • Open-minded team player
  • Structured working manner
  • Reliable working manner
  • Ability to prioritize multiple tasks
  • Ability to work in a changing environment

Tasks

  • Lead process guidance and optimization
  • Document system, software, and assay projects
  • Manage Risk Management processes
  • Manage Requirements Management processes
  • Manage Configuration Management processes
  • Manage Defect Management processes
  • Support multi-level requirements traceability
  • Maintain data in a streamlined database
  • Conduct detailed product risk assessments
  • Analyze documents for risk assessment
  • Analyze reports for risk assessment
  • Analyze market trends for risk assessment
  • Collaborate with cross-functional teams on risk
  • Ensure high-quality risk documentation
  • Establish Configuration Management for complex projects
  • Maintain overview of product configurations
  • Provide Verification know-how
  • Plan Verification activities
  • Guide Verification activities
  • Train teams on Verification
  • Report on Verification activities
  • Act as primary Defect Manager
  • Ensure timely defect resolution
  • Ensure high-quality defect process execution
  • Manage project interactions with Development
  • Manage project interactions with Production
  • Manage project interactions with Customer Service
  • Manage project interactions with Quality
  • Manage project interactions with Regulatory
  • Manage project interactions with external suppliers
  • Gather and consolidate critical information
  • Execute work packages independently
  • Manage personal timelines
  • Ensure timely project documentation delivery
  • Ensure high-quality project documentation delivery

Work Experience

  • 2 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBusiness Fluent

Tools & Technologies

  • Process Management
  • Risk Management
  • Requirements Management
  • Defect Management
  • Configuration Management
  • Database
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche Diagnostics Int. AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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