Quality Control Manager
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AI Summary AI Analysis
The Quality Control Manager will lead QC personnel and oversee regulatory compliance, including CAPA, sterilization validations, and document control. This remote role is ideal for an experienced quality professional looking to manage departmental operations within a highly regulated manufacturing environment.
Job Description
Manage 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.RequirementsIncoming Material InspectionDevice History Records review/releaseReturned Goods receipt, disposition and/or product evaluationEnvironmental Monitoring and ControlNonconforming Material and Product processDeviation processSterilization Validations/RevalidationsSupport for validations and studiesCAPA, calibration and supplier approvalsWriting/revising departmental SOPs/qualifications/validationsParticipate in compliance activitiesOriginally posted on Himalayas
Full Description
Manage 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.RequirementsIncoming Material InspectionDevice History Records review/releaseReturned Goods receipt, disposition and/or product evaluationEnvironmental Monitoring and ControlNonconforming Material and Product processDeviation processSterilization Validations/RevalidationsSupport for validations and studiesCAPA, calibration and supplier approvalsWriting/revising departmental SOPs/qualifications/validationsParticipate in compliance activitiesOriginally posted on Himalayas