Virginia Lopez10610 Barnhill Drive • Austin, Texas 78758 • virginia1126@gmail.com • 512-294-5428

        

Skills Fluent in Spanish and English (written and verbal). Comfortable balancing multiple tasks and performing under deadlines. PC Proficient: Microsoft Office Suite Excellent organizational, detail-oriented, planning, time management, prioritization, task

management, project coordination / completion, and written / verbal communication skills. Strong interpersonal skills. Ability to work independently or in teams both within department and cross-functionally.

ExperienceLDR Spine Austin, TXField Inventory Auditor May 2016 – Present Plan and conduct inventory field audits throughout the U.S. Run reports by location to account for all consignment inventory when in the field. Research and reconcile discrepancies. Perform ERP transactions for discrepant parts. Communicate the audit results with internal personnel and with field agent(s). Assist operations with kit/instrument set upgrades. Assist (as needed) with daily warehouse inventory counts.

Quality Affairs Specialist June 2012 – May 2016 Working knowledge of FDA QSR/GMP and ISO 13485 requirements. Assist with continuous improvements of the quality system. Assist in resolving quality issues. Provide input for current systems and assist with implementing new and/or improved processes. Lead supplier/vendor auditor. Assist with supplier/vendor approvals, and maintain supplier/vendor records. Maintain calibration equipment schedules and records. Lead the MRB (Material Review Board) meeting on a weekly basis for non-conforming material. Document non-conformances using Trackwise. (create Parent Records/Action Items) Assist in Trackwise workflow development meetings and assist colleagues with basic Trackwise training. Generate and maintain all documents used for incoming inspections. Assist with new product training for incoming inspection. Review inspection documents for incoming product. Generate and maintain all documents used for field return inspections. Provide product field return training for the inventory team. Assist colleagues with documenting work flows and processes. Assist with other QA related functions and responsibilities. (i.e.…CAPA/Complaints/Supplier Corrective

Actions)

Ascension Orthopedics Austin, TX Sr. Document Control Specialist May 2011 – June 2012 Maintain and further develop the electronic documentation control system including the creation of

Quality System electronic files and electronic launch and routing of all documentation packets in Master Control according to procedure.

Perform calibration of in-house sterilizers and coordinate equipment calibration activities with external calibration labs.

Coordinate bioburden testing and sterility dose audits and review, approve, and maintain the records of these activities.

Maintain calibration schedules and records. Maintain all paper such as inspection reports, sterility documentation, document supplier notifications,

device history files, control material records, history files and all other documents. Maintain external standard document control system (electronic and non electronic documents) and

assist in purchasing external document using the online ANSI webpage Maintain, update and archive master and supporting document files. Issue document numbers as required. Perform QA review and approval to enable release of device history records, product purchase orders

and sterility reports. Provide Supplier notification of new/updated documents as required. Keep the supplier database updated. Assist with gathering new supplier information. Provide training for personnel in the electronic document management system as required. Launch training courses through master control for all trainees or as required. Maintain personnel training records both electronically and manually. Perform environmental monitoring activities for clean room. Conduct internal quality system audits as required. Help update and maintain all documentation on a yearly basis. Provide manufacturing with sterilization of conformity declaration reports for oversea shipments.

Quality Assurance Associate April 2008 – May 2011 Assist in maintain, update and archive master and supporting document files. Help process document changes electronically and manually. Maintain external documents and standards. Assist with issue document numbers. Review and proofread documents for consistency of format and change control. Confer with document originators to resolve discrepancies. Provide supplier with updated documents notification. Responsible for document archive activities, which may include scanning or preparing documents for

offsite storage. Responsible for issuing and assuring the return of documents from the document control center as

requested. Assist in training for personnel in the electronic document management system as required. Provide support in preparation of required documents for all audits.

Manufacturing Associate January 2006 - April 2008 Process manufacturing materials as specified by documented procedures Complete appropriate records and forms for tasks. Move materials throughout manufacturing warehouses. Inspect incoming material. Sterilize parts. Create purchase orders as required. Conduct monthly and yearly inventory counts. Conduct shipping and receiving procedures. Create quality, professional and supportive working environment. Help train and assist new associates.

Venkel Ltd. Austin, TX

Inventory Specialist May 2003 – January 2006 Run daily reports to process customer work orders. Update work orders in SBT to prevent missing a shipment or double pull. Compare part # with incoming packing slips to ensure proper parts are being received as well as

shipped out. Transfer parts from location to adjust inventory properly. Pull parts from warehouse according to sales order. Send parts for testing to transfer voltage whenever necessary. Get COD and Credit Card information from customer service to prior to shipping. Package materials for safe departure to assure customer satisfaction. Maintain good verbal and written communication with customer service to meet customer’s needs. Make UPS, FED EX labels for packages. Help QC all orders before departure. Help maintain a safe, mature working environment.

3M Selco Austin, TXShipping/Receiving Clerk February 2002 - May 2003 Ship and receive 3M multimedia projectors. Maintain accurate inventory to ensure stock for work orders. Update information in database by RMA number, as well as serial number, product number, tracking

number and other customer information. Duties included, packaging, labeling, keep inventory, prepared packages for UPS, FEDEX pickups, and

other general warehouse duties. Help make UPS and FED EX labels for packages, as well as set up pick up times with BAX and other

freight co. Invoiced, filed and faxed paperwork. Maintained a clean and safe working environment.

Teccor Electronics Brownsville, TXMaterial Analyst August 2000 - October 2001 Receive semi-conductors from corporate company in Mexico. Produced daily reports to insure customer’s orders. Coordinate return goods. Faxing, filing, invoicing, e-mailing documents. Unlading materials, stock up materials in designated area, keeping inventory control, organizing

warehouse by numerical part numbers Verified shipments to ensure customer satisfaction. Printed daily backlogs to ensure correct inventory for shipments. Helped maintain a clean and safe working environment.

 U.S. Army Reserves 812th QM Co.Automated Logistics Specialist September 1997 - February 2003 Counted, weight and measured items of incoming and outgoing shipments to verify information

against bill of lading, invoices, order forms and other records. Conduct physical inventory counts. Help manage workflow and workload in the warehouse. Direct others in preparing outgoing shipments and in performing related duties. Faxed and filed paperwork for future references. Assist other soldiers with their duties as well as help train new soldiers.

Relevant Coursework ISO9001:2000 Internal Auditor Certification Course ISO13485:2003 BSI Course Master Control Course Trackwise Training Effective Complaint Handling, Medical Device Reporting and Recalls – Avoiding Costly Errors Oct. 2014 Internal Auditing Training for ISO 13485 Interactive Educational program:

The Sunshine Act 2016 National Patient Safely Goals Bloodborne Pathogens Fire safety Advamed Code of Conduct Electrical Safety HIPPA, Patient Rights and Responsibilities Infection Control and Aseptic Practices Informed Consent Medical Device Reporting Operating Room Protocols Radiation Safety Spinal Anatomy Test