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Senior Engineer - Design Control Excellence(m/w/x)
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
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Process Management
- Risk Management
- Requirements Management
- Defect Management
- Configuration Management
- Database
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- RocheFull-timeFreelanceOn-siteManagementRisch-Rotkreuz
- Roche Diagnostics Int. AG
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Senior Engineer - Design Control Excellence(m/w/x)
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
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Process Management
- Risk Management
- Requirements Management
- Defect Management
- Configuration Management
- Database
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Roche Diagnostics Int. AG
Industry
Healthcare
Description
The company is dedicated to advancing personalized medicine and improving patient lives through innovative diagnostics and healthcare solutions.
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