Quality Control Manager

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

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