Manager, Data Analytics
US - NY - Rochester - CNP - 100, United States
USD 135K-175K Senior-level Full Time
Tasks
- Compile and present quality data for management review
- Develop and mentor quality professionals
- Drive harmonization and standardization of quality processes and tools
- Drive root cause analysis and implement corrective actions
- Ensure quality systems compliance with ISO 13485 FDA 21 CFR 820 and IVDR
- Establish dashboards and data visualizations
- Lead metrics and analytics for complaints recalls nonconformances CAPA and audits
- Lead process investigations and manage nonconformance records
- Lead quality data handling and analytics
- Maintain inspection readiness for regulators and notified bodies
- Manage and supervise quality engineers and data analysts
- Manage complaint trending activities
- Monitor quality performance using metrics and analytics
- Prioritize work assignments and allocate resources
- Promote continuous improvement in the QMS
- Provide quality regulatory and operational leadership
- Validate quality analytics software systems
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR 820 | CAPA | CFR 820 | Cause analysis | Complaint Trending | Dashboards | Data Visualization | Data analytics | FDA 21 CFR | FDA 21 CFR 820 | ISO 13485 | IVDR | Inspection Readiness | Management systems | Nonconformance management | Process validation | Qms | Quality Management Systems | Quality management | Quality metrics | Regulatory Compliance | Regulatory Inspection | Regulatory Inspection Readiness | Root Cause Analysis | Root cause
Education
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