GORDON Wm. SPARKS, CQE

13600 Redstone St Lathrop, CA 95330
209/513-5663
408/398-9522
Fax: 209/944-7811
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Sr. Quality Engineer for Medical Devices

• Solid understanding of GMP Medical Device specifications and standards, including, FDA QSR 21 CFR Part 820, ISO 9001:2000, ISO 13485:2003, QMS systems and QSIT audit process.
• Superior investigative and analytical skills solving complex supplier quality problems.
• Proven track record managing all aspects of domestic and international supplier, internal, and customer quality issues. This includes process validation review of both piece parts and finished goods.
• Extensive technical writing and presentation abilities. Proficient in Excel, Word, Publisher, Visio and PowerPoint.

EXPERIENCE

• Resolved open Supplier Corrective Action backlog
• Coordinated with Suppliers to determine true cause of discrepant material; internal or supplier.

PHILIPS MEDICAL SYSTEMS, Milpitas, California Jan 2000 to Jan 2003
Sr Supplier Quality Engineer

• Managed the supplier quality process for key components. Reviewed and accepted Process Validation and 1st Article Reports. SCARs were generated to document discrepancies. Responsible for resolution/verification/closure of all supplier related activities.
• Audited Manufacturing facility to FDA specification 21 CFR 820.181, Device Master Record and discovered shipments of discrepant piece parts. Internal CAPA was generated based on concise and complete report.
• Reviewed and accepted all applicable documentation/specification changes through the Engineering Change Control (ECO) process for Supplier Quality.
• Generated executive reports and management presentations based on supplier quality data analysis.

• Dispositioned all discrepant Manufacturing material and coordinated supplier rework. Purged Stock Room to verify units met specifications.
• Designed and developed Discrepant Material Process Flows in Purchasing, Material Planning, Manufacturing, Receiving/Stock and Shipping areas.

• Initiated and managed Interdepartmental Task Force that corrected spare part issues with key customer in Singapore. Presented results and action plan to customer.
• Division representative to the Product Development Program that optimized the release of new tools and modules.
• Responsible for final approval of tool shipment to customer. Verified the proper tool configuration based on the customer and internal specifications.

• Managed all Quality and Reliability tasks in the Santa Clara facility. This included Calibration, Document Control, and Customer Returns.
• Coordinated successful ISO-9001 registration. This involved modifying and verifying design, test and shipping procedures.
• Discovered a major supplier semiconductor packaging anomaly which reduced product performance. Because this issue was detected before high volume production was initiated, thousands of dollars in customer returns were saved and a product recall was avoided.

• Calculated, analyzed and interpreted mainframe computer MTBF predictions using Weibull statistical techniques in Excel.
• Published monthly reliability failure rates data based on MIL-HDBK-217 as part of the module qualifications process.

EDUCATION

PROFESSIONAL ORGANIZATIONS

• Member since 1981
• Silicon Valley Section Arrangements Chairperson since 2000

LICENSES

Gordon Wm. Sparks, CQE
13600 Redstone St Lathrop, CA 95330
Cell #1: 209/513-5663
Cell #2: 408/398-9522
Home: 209/234-2808
Fax: 209/944-7811