Carol Ott Email & Phone Number

New Bern, Nc, Us

United States

United States

Tucker, Georgia

Cross trained in multiple sections: Final Inspection, Clean Room, Human Test Trial Sample Section, Incoming Inspection, and Distribution, Shipping / Receiving. Final Inspection:Responsible for performing precise inspection/testing of Surgical Instrument’s from production per production order, engineering drawings and samples. Instruments were returned back to production for packaging. Once packaged inspected for correct label, IFU and CE marking. Responsible for entering into BCPS and forwarding to shipping.Human Test Trial Samples:Received from Sales Rep, Human Test Samples in from the field and performed Sterilization and Decontamination on every sample received. Inspected and tested instrument for function, packaged and entered into Impress system and SAP.CME:Responsible for inspecting sterile product after packaged and heat sealed into proper packaging. Inspected for correct seal, no foreign particles in packaging and verify correct label and box used per production order.Incoming:Inspected Incoming products by mechanical and visual inspections per engineering drawings, completed data sheet to accepted or hold. Properly identified inspection status of product and moved to designated area.If product was nonconforming it was properly identified, marked and an MRR was created.Performed First Article Inspections on new instruments using various handheld equipment Calipers, Micrometers Height Gages and MicroVu.Distribution / Shipping-Receiving:Performed cycle counts in distribution as well as pulling orders for production, entered into BCPS.Responsible for pulling, packing and shipping orders, creating either a UPS or FED label. Responsible for entering all data into BCPS and SAP.

Duluth, Georgia

Responsible for Inspection of incoming raw materials and assemblies, per spec drawings and purchase requisition. Responsible for in-coming, in-process and final inspection on all Satellite Communication equipment for both Commercial and Military programs.Responsible for production support, problem solving, root cause analysis.Responsible for collecting, structuring and registering embeded data using UID (Unique Identification) software for Military programs.Manage and track Government and Commercial Furnished Equipment thru GFE/CFE database.Implement and manage Return Material Authorization (RMA) and failure analysis data base while processing and tracking all repairs. Coordinate between customer, vendor and program management for all repairs.Keep detailed records of customer interactions and transactions, recording details of inquired complaints and comments as well as actions taken.

Lawrenceville, Georgia

Managed the day-to-day activities and directed 13 Quality Control Inspectors, Supervisor and Claims Coordinator.Streamlined inspections, increased efficiency, and improved overall product defect.Analyze quality control test results and provided feedback and interpretation to upper-management.Brainstormed with R&D and Production to identify and resolve quality problem areas.Recommended and implemented new process inspection, which decreased inspection time by 25%, which increase inspections capability with out jeopardizing quality.Created Certificate of Analysis and Certificates of Conformance for product to send with shipment.Assure failures that occur are adequately analyzed, appropriate root cause determination is made, and appropriate/corrective/preventive action is taken.During Internal and External auditing responsible for Zero Major Non-Compliance for Quality Inspection, Document Control, Corrective/Preventive Action, and Customer Complaint Process within the Quality System.Inventory control management of raw, in-process, final inspection and customer returned material.Supported the converting/slitting section with quality inspections.

Trained/developed and coached 13 Quality Control inspectors on procedures, inspection, lab equipment, safety protective personnel equipment and environmental awareness. Staff scheduling, attendance, employee performance reviews.Inspected non-conformance products to determine if material is reworkable or need to be rejected.Performed lab equipment maintenance, validation and accuracy verified each month to ensure equipment within specifications.Documentation review of procedures/forms for internal/external quality audits.Implemented new inspection process, which identified and led to correction of potential defects.Developed and implemented complete overhaul of tracking system of in-process and final inspection results instituting efficient and time saving. Resulting in the elimination of 90% of data entry errors.

Developed and implemented new section for customer returns.Created/maintained logs, spreadsheets, charts, for all customer returned material.Received customer returned material in ensuring material matched return authorization.Inspected material and confirmed defect, documented results and forwarded to our customer service section.Created CAR (corrective action request) and submitted to appropriate section for corrective action.Transferred material to defect inventory and scheduled rework with production control.Maintained defect inventory of customer returned material with 100% accuracy each month.

Inspected Quality of Direct Thermal Paper using calibrated lab equipment.Experienced in operating and calibrating lab equipment.Precision MeasurementQuality Control - Raw Materials, In-Process and Final Inspections. Ensure all material is within product specification.Interface with on line production operators on quality concerns