United States onlyManage Quality Control personnel and ensure the department meets regulatory and company requirements. Develop and maintain metrics for areas of responsibility, provide QC support and expertise during Health Authority Inspections, and review document changes and labeling.
Requirements
- Incoming Material Inspection
- Device History Records review/release
- Returned Goods receipt, disposition and/or product evaluation
- Environmental Monitoring and Control
- Nonconforming Material and Product process
- Deviation process
- Sterilization Validations/Revalidations
- Support for validations and studies
- CAPA, calibration and supplier approvals
- Writing/revising departmental SOPs/qualifications/validations
- Participate in compliance activities
