Beth Husted Email & Phone Number

Las Vegas, Nevada, United States

Seattle, Wa

FDA and ISO 13485 Audit facilitationLead AuditorCAPA managementNCR and Deviation review and managementCustomer complaint review and closureCreation, review and revision of corporate Quality SOP'sReview of Batch records for release

Management of supplier and internal audit programsDevelopment of supplier quality agreementsManagement of document control processesPreparation and facilitation Quality Management Review meetingsReview of all quality and product specification documentation for accuracy and regulatory complianceOversight of investigation programs including- CAPA, Complaint, and Supplier Corrective ActionFacilitation of regulatory compliance inspectionsDevelopment, interpretation, implementation of quality policies and proceduresReview of quality metrics to implement continuous improvements; Management of all aspects of GMD’s Quality System to conform to applicable FDA GMP regulations and ISO standards. Reviewed/revised/created and approved all SOP’s and product specification documentation to achieve compliance with regulatory requirements. Monitored and maintained Quality System to streamline and identify gaps in procedures and processes. Created/maintained internal and supplier quality audit schedules. Assigned team members and conducted internal and supplier quality audits. Managed all Document Control processes. Maintained and tracked all employee quality training. Served on Material Review Board committee. Participated on Design Review Board.

Seattle, Washington, United States