Quality Assurance Engineer

Nelson Andrade

**** ********* ****** #** *********: 650-***-****

Santa Clara, CA 95051 E-Mail: **************@*****.*** Page 1 of 3

SUMMARY

Results oriented professional with over 15 years of experience in Quality Assurance Engineering, having outstanding planning, organizational, problem solving, interpersonal and communication skills with an exceptionally detailed quality oriented mindset. Areas of expertise include managing Quality Assurance projects in engineering and production organizations for the Electronics and Commercial Aerospace Industries. Extensive experience with Quality Management Systems (QMS), supplier quality and auditing, customer quality, Corrective Action Requests (CARs), Corrective and Preventative Actions (CAPA), ISO 9000, document control, procedure and specification development, establishing quality systems, calibration control/support, and Continuous Improvement (CI). EDUCATION

CALIFORNIA STATE UNIVERSITY, Fresno, CA

Bachelor of Science, Electrical Engineering, Minor in Math EXPERIENCE

Caregiver and Volunteer, Santa Clara, CA Oct 2015 – Present Primary caregiver, for a friend, for several months, until May 2016. Joined a civic/fraternal organization (Knights of Columbus) and currently volunteer my time with them. I am involved in areas such as: community breakfasts at a local church, assisting senior members of the organizations with overall: action items, budgeting and setting fundraising goals, and idea generation for fresh and innovative ways to recruit and retain members. SPACE SYSTEMS LORAL, Palo Alto, CA Aug 2006 – Sep 2015 Quality Assurance Engineering Specialist

Supported and drove supplier quality assurance for high reliability satellite products procurement quality organization. Performed source inspection of equipment, mechanisms, machined parts and assemblies, control sensor electronics, printed circuit boards (PCBs), and RF products. Reviewed test data as needed as part of hands on source inspection process. Performed surveillance and audit of vendor activities to rapidly recognize performance problems, identify their causes, isolate critical risk, and assist in their resolution. Interfaced with customers on QA activities.

Traveled and responded with agile actions as representative for Palo Alto and west coast supplier quality.

Facilitated timely closed-loop corrective actions, of supplier non-conformances, including non-conformance reporting, quick turnaround cycles, and steer supplier quality measures through the use of Corrective and Preventive Action (CAPA) system.

Resolved supplier quality issues in Material Review Board (MRB) actions/teams to resolve supplier issues.

Led audits of new and existing suppliers. Worked closely with Purchasing, Engineering, and Program management to evaluate new suppliers. Audits included elements of AS9100 and ISO 9000.

Concurrent to supplier audits and post-supplier audits, subsequent to findings, I reviewed and evaluated processes to help supplier to correct their quality systems or procedure deficiencies and to formulate improvements needed.

Resolved technical and schedule problems, with internal stakeholders and suppliers.

Generated concise and thorough reports. Audit report of mine was utilized for training as good example to follow.

Source inspections included: First Article Inspections (FAI), review of supplier’s End-Item-Data-Package (EIDP), workmanship quality, in-process quality against purchasing contract requirements.

Identified and communicated supplier non-conformances and other quality issues while in field. Drove improvement of supplier processes.

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Measured supplier process performance before and after process improvement implementations.

Drove supplier process changes for their implementation and conformance to improvement plans. Provided feedback as applicable.

Interacted closely in cross-departmental activities, and with suppliers, to ensure and/or improve supplier performance and products, as well as cost reductions.

Achieved cost reduction for company by multi-tasking multiple supplier travels in one trip, and demonstrated best practices for daily travel costs.

Examples of typical suppliers: RF, Microwave (passive and active), Hybrid Circuits, Printed Circuit Boards

(PCBs), PWB Assemblies (PWBAs), machine shops, other electrical devices/systems and mechanical hardware. ASIC ADVANTAGE, Inc., Sunnyvale, CA Aug 2005 – Jan 2006 Quality Assurance Engineer

Provided overall quality assurance support to supplier of aerospace, and commercial electronics. Supported test, production, sales, and marketing to improve compliance with ISO 9001:2000 requirements.

As Lead Auditor of Internal Audit program I 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.

Analyzed gaps in company’s Electrostatic Discharge (ESD) controls. Implemented control to entire facility.

Maintained quality metrics: internal operations, supplier quality, failure analysis, reliability, design, and test. U.S. DEPARTMENT OF VETERANS AFFAIRS, Menlo Park, CA Apr 2003 – Apr 2005 Quality Assurance Specialist

I led quality assurance and compliance efforts for clinical studies program of the Research and Cooperative Studies division and managed resolution of quality, compliance, systems and documentation issues. Projects were in: cardiology, renal, DNA banking, and behavioral studies.

Monitored and ensured compliance of clinical studies protocols to CFR, ICH, and GCP requirements.

Performed internal audits of clinical studies’ documentation, for any gaps, 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.

LSI LOGIC (Semiconductor and Electronics Developer), Santa Clara, CA May 1994 – Sep 2001 Quality Assurance Engineer

Drove, enhanced, and maintained reliability, audits, procedures and document control systems and conducted improvements to internal quality, supplier quality and customer quality. Provided guidance to organization on quality requirements ranging from internal, supplier, and customer quality aspects.

Managed audit preparations and closures and successfully completed ISO 9001 registration and customer audits for Sony, Intel, Sun Microsystems and Compaq Computers.

Managed/coordinated action items for those in other organizations.

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.

Supported new process qualifications through Gage Repeatability & Reproducibility (GR&R) methods and Page 3 of 3

utilized statistical analyses that determined total GR&R capability.

Evaluated lower-cost second source suppliers for critical materials and services based on input from Engineering and ensured the suppliers’ satisfactory compliance and delivery.

Managed Calibration program for facility. Interfaced with outside calibration labs and field service to facilitate timely calibrations, of instruments, gages, and metrology tool to meet applicable calibration requirements.

Achieved cost savings in internal and external supplier services, including $12,000 in metrology savings, through analysis of calibration and preventive maintenance field service reliability.

Trained and updated personnel on quality procedures.

Influenced personnel in multi-disciplinary areas to take ownership of quality objectives and actions.

Owner of Document Control and Engineering Change Notice (ECN) processes in my organization.

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 process of critical materials suppliers and expanded improved results which was adopted by outside organization in another part of the corporation. Achieved cost savings so that efforts would not be duplicated.

LOCKHEED MISSILES AND SPACE CO., Sunnyvale, CA May 1987 – Jan 1994 Materials and Process Engineer

Supported materials and process engineering at Aerospace Electronics and Solar Array Manufacturing group.

Improved electronics assembly process and clean-room operations by using hands-on lab testing and analysis of Electrostatic Discharge (ESD), circuit board cleanliness, printed circuit board (PCB), 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.

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. COMPETENCIES

Training: Regulatory and Compliance topics, ISO 9000, Quality Systems Regulations (QSR), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) Computer Skills: PC working knowledge, Microsoft Office Suite, FrameMaker, SAP, AutoCAD Affiliations: American Society for Quality (ASQ) (1996-2002); Past Treasurer of Silicon Valley Electrical Overstress/Electrostatic Discharge (EOS/ESD) Society (1992-93). Certifications: Engineer-in-Training (EIT) Certificate References Available Upon Request; Willing to Travel; U S Citizen

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