Quality representative for New Product Introduction (NPI) ensuring a smooth and seamless transition from design/development to full production.

Managed two Quality Engineers. Ensured product quality & reliability across diverse market range. Maintained ISO Quality Management System by authoring procedures and conducting internal audits. Served as Global Application Administrator for Quality related software applications. Led customer complaint and Corrective Action/Preventative Action (CAPA) investigations. Facilitated risk assessments utilizing Failure Mode & Effects Analysis (FMEA). Established inspection plans to ensure quality control of incoming raw materials, in-process & finished goods. Developed and conducted training on SPC, Gage R&R & Process Capability to enhance production employee knowledge. Determined calibration requirements and assisted in test method development. Performed data analysis to identify largest causes of waste and underlying root causes. Authored & executed Pharmaceutical style process & software validations (IQ/OQ/PQ). Supported Operations including troubleshooting and continuous improvement activities. Assisted Purchasing with supplier management and qualification. Reviewed external standards, engineering and regulatory documentation.Led cross-functional team that modified product design to reduce dimensional variation and particulate shedding by 50%. Initiated the search & justified an improved electronic data collection/SPC system to replace the existing system which had limited ability to provide results oriented analysis. Installed, validated, configured and trained on the new SPC application at both the U.S. and India sites. Configured operator interface to allow production operators to view a real-time, electronic version of procedures, metrics and safety information. Identified & implemented a solution to repetitive audit findings in the Quality Lab regarding 21 CFR Part 11 compliant Excel spreadsheets. Coordinated and conducted Production Part Approval Process (PPAP) for automotive parts.

Transitioned to R&D to lead product development in the Electronics market. Reduced prototype builds from 6 weeks to 3 days by identifying and implementing off-the-shelf equipment to closely approximate future production-made parts. Developed a dimensional variation matrix based on analysis of long term historical data. This provided an accurate basis for specification determination; reduced development time & costs. Created a Design for Manufacture (DFM) document providing realistic expectations of new products to largest customer.

Established and maintained inspection plans for incoming raw materials, in-process & finished goods. Co-inventor of the “Sorbent Capsule” resulting in a patent (US 6,929,682 B2) developed while pursuing product improvements to Multiforms product line. Solved dimensional discrepancy complaints with second largest customer by utilizing Gage R&R to identify the source of variation, then identifying, implementing, programming and training on the use of a vision-based measurement system to effectively eliminate dimensional complaints. Led implementation, configuration and training of electronic SPC system across 50% of the company, reducing time to locate historical data and provide real-time feedback to operators. Participated in Natural Work Team that was recognized as Work Team of the Quarter for identifying and improving process/part variability and defining process parameters to ensure conforming product.

Created inspection plans for finished goods. Provided analytical support to production. Transitioned role from reactive (customer complaint focus) to preventative (heightened initial testing at time of qualification and meaningful root cause investigations).

Coordinated customer complaint receipt, investigation and response.

Supported Staff Engineer in start-up of newly installed ink making system.