Waters
Life Sciences
QualityEngineerII
“Quality Engineer II at Waters. Skills: Quality Compliance, Documentation, Data analysis, Risk Management. Champion Quality Compliance. Maintain ISO requirements”
Industry & Context.
Root cause analysis; Failure analysis; Risk assessment
What They're Looking For.
Must Have
Bachelor's degree, 2+ years' experience in Quality Assurance, 2+ years' experience in Quality Control, 2+ years' experience in Product non-conformance investigations, 2+ years' experience in Process non-conformance investigations, Experience in medical device manufacturing facility, Experience in pharmaceutical manufacturing facility, SAP transaction experience
Nice to Have
Medical Device Validations, First-hand audit experience, Microbiology/molecular science background, Data efficiency optimization, Manual assembly manufacturing experience, Microbiological test methods, Chemical test methods
What You'll Do.
Champion Quality Compliance
Maintain ISO requirements
Maintain regional regulatory requirements
Develop Device History Files
Maintain Device History Files
Drive Quality Intelligence
Provide recommendations
Lead Product Integration
Support product integration
Ensure Regulatory Excellence
Meet regulatory requirements
Perform trend analysis
Perform risk management
Apply Six Sigma tools
Support instrument platforms
Support sustaining activities
Support non-conformances
Support operational challenges
Lead root cause investigations
Collaborate with Operations
Collaborate with key departments
Process change controls
Process deviation waivers
Influence product quality
Influence customer satisfaction
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Work closely with R&D; Work closely with Operations
Process & Methodology
Change management plan execution
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