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Director, Quality Assurance

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PROFESSIONAL EXPERIENCE

• Managed Plant QA function for the Intravascular Ultrasound Imaging and Neurovascular Divisions, and the Equipment Service Business. Responsibilities include: Division management boards, management representative, quality/reliability engineering (new product development), incoming/in-process quality control, supplier quality management, manufacturing support, document control, post-market surveillance, internal audits, regulatory submissions support and agency interface.
• Achieved ISO 13485:2003 quality system certification. Contributed to the development and CE marking of several new products. Improved the complaints management and CAPA processes. Implemented problem solving methods for process/product quality improvements. Successfully completed FDA, and several Notified Body audits of the quality system. Established quality goals and metrics, reviewed periodically with corporate executive management, and drove continuous improvement processes.

• Managed quality & reliability including both hardware and software QA for the Respiratory Care Divisions. Established Reliability/EMC/CSA Electrical Safety labs for in-house product testing & qualification, which significantly improved time-to-market and product costs.
• Established and maintained the division quality system in compliance with FDA QSR, ISO 13485/ISO9001, MDD, ISO 13485/CMDCAS, and other International Standards.
• Established quality system procedures, supplier qualification, verification & validation processes, quality improvement program, internal audits, CAPA system, supported regulatory submissions, and quality system training. Led several successful quality system audits by both FDA and Notified Body. As management representative conducted executive management reviews of the quality system compliance, MDR/vigilance reporting, manufacturing process quality, and continuous improvement processes.

• Managed quality assurance and product technical support, design verification & validation testing, reliability engineering, metrology, and ISO 9001 program functions with a total of 25 professional employees.
• Directed worldwide customer satisfaction team in understanding and resolving customer issues, which resulted in 50% improvement in customer satisfaction index, as measured by worldwide customer surveys.
• Implemented strife and reliability growth testing, root-cause failure analysis and corrective action processes. This resulted in an estimated 30% increase in process yields, improved product quality and enhanced disk drive MTBF to over 300K hours. Presented worldwide product performance metrics to executive management.

• Managed reliability analysis, design verification & validation, reliability growth testing required for successful product qualification/launch into manufacturing, and Ongoing Reliability Testing at five world wide manufacturing sites.
• Developed and implemented standardized corporate reliability testing, failure analysis and corrective action processes for worldwide manufacturing sites, which resulted in disk drive MTBF in excess of 200K hours.
• Implemented improved failure analysis methods and procedures, resulting in 60% improvement in analysis turn around time, effective corrective/preventive actions leading to customer satisfaction.
• Periodic review of product performance trends, and corrective/preventive actions with executive management.

• Managed 25-employee department performing reliability analysis, design verification & validation testing, ongoing reliability testing, electronic components engineering, failure analysis, materials and components analysis. This in-house testing and analysis capability contributed to timely resolution of quality issues, improved process yields and product quality, and saved an estimated $2 to $3 million per year.
• Developed and implemented standardized corporate ongoing reliability testing, failure analysis and corrective action processes, which resulted in drive MTBF improvements to over 150K hours.
• Implemented corporate product quality and failure analysis database, which provided management immediate access to quality issues and ensuing corrective/preventive actions.

• Managed 30-employee component engineering groups responsible for qualifying ASIC devices, memories and microprocessors, PCBs, connectors, and other electronic components used in all of Unisys products.
• Developed and implemented supplier self-qualification process, which reduced components qualification time by about 50% and reduced qualification costs by approximately $2 million.

• • Directed and administered the division’s quality management activities, including supplier quality management, quality engineering, process quality control, document control, and achieved division’s quality goals and objectives.
• • Managed 50+ personnel QA function including receiving inspection, manufacturing of thin film magnetic head arm assembly and disk drives manufacturing. Implemented SPC resulting in 4-fold improvement in quality.

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