Sr. Manager, Quality Systems Governance & Analytics
USA - KS - McPherson - Hospira, United States
R
USD 139K-231K Senior-level Full Time
Tasks
- Approve quality lifecycle documentation
- Create dashboards and reporting routines
- Develop and mentor team members
- Establish quality systems governance
- Manage quality data and KPI governance
- Manage resources for quality projects
- Oversee medical device quality support
- Oversee training strategy and execution
- Oversee validation quality activities
- Perform trend analysis
- Provide quality systems leadership
- Resolve inspection issues cross functionally
- Review validation protocols and reports
- Support CAPA coordination
- Support design controls and risk management
- Support regulatory and third party inspections
- Translate data insights into preventive actions
Perks/Benefits
- 401k matching
- Dental insurance
- Health insurance
- Medical leave
- Paid Holidays
- Paid vacation
- Parental leave
- Personal days
- Relocation assistance
- Vision insurance
Skills/Tech-stack
21 CFR | 21 CFR 820 | CAPA | CFR 820 | CGMP | Change Management | Complaint handling | Continuous Improvement | Dashboard Reporting | Data Integrity | Design Controls | Documentation review | GMP | GMP Documentation Review | GMP documentation | ISO 13485 | ISO 14971 | KPI governance | LMS | Lean | Learning Management System | Learning management | MDCP | Management System | Medical Devices | Nonconformance management | PLS | Project Management | Quality Management System | Quality management | Regulatory Inspections | Risk Management | Six Sigma | Training Management | Trend analysis | Validation
Education
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