Quality

• Dec 2011 - Present

Supply Quality Engineer

• Aug 2007 - Oct 2008

Perform initial assessments and periodic audits of supplier quality systems for the purpose of approving new suppliers and verifying continuing supplier conformance to quality system requirements. Initiate and follow-up supplier corrective actions to ensure complete and effective root cause analysis and corrective action implementation. Act as liaison for the supplier and the company to resolve nonconformances and quality problems effectively by interacting and communicating with engineering, purchasing, planning, program quality engineers and various levels of management of the supplier and the company. Develop appropriate and effective supplier metrics to monitor effectiveness of supplier quality control system and processes. Develop and assist with implementation of supplier quality control and process control plans as required for supplier operations. Develop and implement statistical process controls of supplier processes as appropriate or when required by customers. Work with SQE team to develop supplier performance reports and process. Participate with SQE team in maintaining the dock-to-stock process. Develop positive relationships and effective lines of communication with suppliers, customers, and government officials. Show less

Supply Quality Engineer

• Sep 2006 - Jul 2007

Left as part of a staff reduction due to order shortfall) Supplier Quality Engineer Worked with planners (commodity leaders) and buyers to put improvement plans in place for on-time delivery and other quality measures. Monitored and drove corrective action and continuous improvement activities which produced a $65,000 cost reduction. Performed and coordinated supplier surveys and quality system and process control assessments that resulted in a 10% increase in product flow. Developed and communicated Elster Electricity's expectations for quality performance, continuous improvement, quality systems, process control infrastructure for high leverage/ critical sustaining parts and new products sources to contract manufacturers. Supported sourcing projects for supplier and part qualification as needed. Reviewed and approved PPAP data when required Show less

Quality Auditor

• May 2004 - Sep 2006

Responsible for implementing the Corporate Audit program and managing all aspects of the correction action planning process related to audit findings. Identified and implemented improvement opportunities that increased the work flow by 35% from previous year Participate and support facility management in implementing improvement initiatives using cross-functional and cross-facility team approach. Provide coaching and training in QS objectives related to cGMP/QSR/ISO, SOPs, and specific audit-related functions. Responsible for managing the development, approval, and control of related corporate level standards, policies, procedures and standardization of facility SOPs based on best practices. Show less

Quality Technician II

• Feb 2004 - May 2004

Assist in testing projects with other technicians on components and assist in drawing interpretation using GD&T. Assist in nonconforming product evaluations to be dispositions through the material review board committee Analyzed and solved with the Medical Affairs department and Customers Services department customer complaints Perform product release on components as well as instruments to help get ready for the customers orders Involve in Six-Sigma projects to help reduce backorders by $80,000-$100,000 for the year. Show less

Quality Technician

• Oct 1996 - Jan 2002

Performed and assisted in performing quality assurance routine tasks to develop, apply, and maintain quality requirements for processing components and other material into finished products in a FDA pharmaceutical industry Familiar with a wide range of quality measurements and gages such as: calipers, micrometers, tool makers microscope, CMM, steel rules and optical comparators Analyze and solve quality related problems such as NCMR reports, deviations and preparation of standard operating procedures Show less

Production Planner

• Jan 1998 - Oct 1999

Ensured that the work centers were set up with work orders and materials.Assigned various work status and reported any material shortages to the production manager.Provided support to the production group for inventory control issues.Reconciled work orders by reviewing material transactions and interfaced with purchasing operations.Reviewed and revised schedules according to work order specifications, established priorities, capacity, parts and materials availability.

Production Operator

• Oct 1996 - Jan 1998

Inspected work in progress components for physical defects.Operated wash plant machinery; ensuring components properly completed the wash plant cycle.Operated all deep draw metal machinery used in the production process.Trained new-hires on machine operation, packing, shipping and wash plant procedures.Completed training on all aspects of production planning for a manufacturing environment.