The ideal candidate will be a hands-on problem solver with excellent analytical and organizational skills, who thrives in an environment that encourages and rewards superior work. You should be passionate about innovation and developing new skills, and excited to take on the challenge of contributing to the next generation of engineering tools and systems.
Primary Responsibilities
• Work with quality engineers, supplier engineers and suppliers to monitor products performance, identify trending issues. Prioritize based on Severity, occurrence, and/or cost of each failure modes
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Participate in continuous improvement activities and take preventive actions.
Share Lessons Learned from previous field issues; Provide upfront feedback by participating in design reviews to ensure product performance, reliability, and manufacturability issues are identified and risks mitigated. (DFMEAs)
Take part in ongoing optimization of the products and processes (performance, cost, technology)
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Participate in continuous improvement activities and take preventive actions.
Share Lessons Learned from previous field issues; Provide upfront feedback by participating in design reviews to ensure product performance, reliability, and manufacturability issues are identified and risks mitigated. (DFMEAs)
Take part in ongoing optimization of the products and processes (performance, cost, technology)
...
Testing Strategy & Quality Oversight: Define and review test strategies, test plans, and test reports in collaboration with product owners and technical teams. Provide consultancy on test-related deviations, corrective actions, and preventive measures
Change Control & System Maintenance: Assess the validation impact of system changes, enhancements, and patches – ensuring that the validated state is preserved across all system updates and that change control processes are followed in accordance with Roche SOPs
Deviation & CAPA Management: Support deviation investigations to identify root causes and define corrective and preventive actions (CAPAs), ensuring timely closure and regulatory compliance
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