Nelson Andrade

SUMMARY

COMPETENCIES

EXPERIENCE

• Perform surveillance and audit of vendor activities to rapidly recognize performance problems, identify their causes and assist in their resolution.
• Representative for Palo Alto and west coast supplier quality. Extensive travel both locally and out of state.
• Ensure closed-loop corrective actions, of supplier non-conformances, quick turnaround cycles, and steer supplier quality measures through the use of Corrective and Preventive Action (CAPA) system.
• Resolve technical and schedule problems, with internal stakeholders and suppliers.

• Lead Auditor of Internal Audit program: trained and coached auditors, planned and scheduled, prepared audit reports, ensured root cause, and corrective actions, as well effectiveness verification.
• Audited suppliers of critical processes and services, to applicable ISO and MIL-SPEC requirements.
• Maintained quality metrics: internal operations, supplier quality, failure analysis, reliability, design, and test.

• Monitored and ensured compliance of clinical studies protocols to CFR, ICH, and GCP requirements.
• Performed internal audits of clinical studies’ procedures and documentation for adherence to regulations.
• Transitioned the center and study sites to compliance with requirements of Health Insurance Portability and Accountability Act (HIPAA) and guided them in updating their files and documentation per HIPAA.
• Directed timely flow of clinical studies documentation, which kept stakeholders appraised of status changes.
• Analyzed electronic signature procedures from various sites and ensured compliance with 21 CFR Part 11.
• Developed and implemented paperless SOP revision processes and procedures in collaboration with quality assurance staff from remote offices and trained colleagues on SOP revisions.
• Coordinated with project managers, research and site partners at various levels and resolved discrepancies.
• Maintained database and controlled files of clinical studies documentation and ensured efficient and timely tracking of clinical documents.

• Managed audit preparations and closures and successfully completed ISO 9001 registration and customer audits for Sony, Intel, Sun Microsystems and Compaq Computers.
• Resolved Discrepant Material Reports (DMR) and Corrective Actions Requests (CAR) and streamlined processes utilizing root cause and analysis tools.
• Ensured closed-loop corrective actions resulted in quick turnaround cycles and steered internal quality measures through the use of Corrective and Preventive Action (CAPA) system.
• Evaluated lower-cost second source suppliers for critical materials and services based on input from Engineering and ensured the suppliers’ satisfactory compliance and delivery.
• Delivered cost savings in internal and external supplier services, including $12,000 in metrology savings, through analysis of calibration and preventive maintenance field service reliability.
• Visited production plant routinely and resolved issues that prevented or delayed production development.
• Trained and updated personnel on quality procedures and influenced them to take ownership of objectives.
• Ensured efficiency of Document Control and Engineering Change Notice (ECN) processes by writing technical summaries using Framemaker and CMS tools.
• Communicated team projects and Cycle of Quality (COQ) goals to the management and achieved those goals through the use of quality engineering DMAIC methods.
• Reengineered qualification and certification of critical materials suppliers and expanded improved results across the corporation.

• Improved electronics assembly process and clean-room operations by using hands-on lab testing and analysis of Electrostatic Discharge (ESD), circuit board cleanliness, cable assembly and solar cells.
• Established and updated standards for incoming materials, supplier qualification, equipment and processes.
• Served as member and chair of Problem Focus group, Organizational Enhancement and Self-Directed teams and developed leadership and team building skills that supported organizational initiatives.
• Implemented and utilized SPC methods and software that optimized manufacturing processes and generated daily and periodic reports of process metrics.
• Monitored product assembly facilities for compliance with industry requirements and local guidelines and worked closely with product assurance, production and engineering and reconciled discrepancies.
• Evaluated and qualified critical materials suppliers and performed lab testing and test report documentation.

EDUCATION