Sr. Manager, Quality Systems Governance & Analytics
USD 139K-231K Senior-level Full Time
Tasks
- Coach and mentor team members
- Direct validation support quality activities
- Establish governance for quality systems activities
- Lead KPI governance and dashboard reporting
- Manage project milestone tracking and escalation
- Oversee CAPA coordination and project specialist activities
- Oversee MDCP quality support activities
- Oversee quality data and analytics
- Oversee training strategy and execution
- Perform trend analysis for preventive actions
- Provide quality systems leadership
- Resolve cross functional quality issues
- Support regulatory and third party inspections
Perks/Benefits
- 401k matching
- Caregiver parental leave
- Dental insurance
- Health insurance
- Medical leave
- Paid Holidays
- Paid vacation
- Relocation assistance
- Vision insurance
Skills/Tech-stack
21 CFR | 21 CFR 820 | Analytics | CAPA | CFR 820 | CGMP | Change Control | Change Management | Combination Product Quality | Dashboard Reporting | Data Integrity | Decision Making | Design Control | Documentation review | GMP | ISO 13485 | ISO 14971 | KPI | LMS | Lean Six Sigma | Medical Device | Medical device quality | PLS | Product Quality | Project Management | Quality Agreements | Quality Systems | Quality management | Risk Management | Risk-based | Risk-based decision making | Six Sigma | Supplier Quality | Supplier Quality Management | Training Management | Trend analysis | Validation
Education
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