Michelle Kyker

While at the Industrial Extension West Virginia Manufacturing Extension Partnership, Michelle worked with small to medium-sized manufacturers to develop and lead programs to increase growth, market share, profits and promote continuous improvement and effective problem solving.

ISO/Quality Management Systems

Michelle was responsible for assisting manufacturers in implementing and maintaining certifications for ISO 9001 (QMS), ISO 14001 (Environmental), AS9100 (Aerospace including AS9110 and AS9120), API Q1 (Oil and Gas), RC14001 Responsible Care (Chemical) and other management system standards.  She conducted process internal audits, developed procedures and documents needed, and performed risk assessments. Her responsibilities included developing and conducting management/employee training and worker development programs. Michelle also assisted and directed continuous improvement and strategic planning initiatives, development of KPIs and coordination of audits.

Throughout West Virginia, Ohio, Virginia, North Carolina, and San Paulo, Brazil, Michelle helped to implement, maintain, and improve quality management systems, continuous improvement projects and overall performance of 75+ companies during her 12 years at the WV MEP.

Michelle began her career as Quality Assurance Manager for Dyna-Mix, a manufacturer of custom mixed rubber, where she was responsible for the implementation, management, and auditing of the ISO 9001 QMS.  Her responsibilities for facilities in four states included training, implementation, certification, and recertification.  She also performed internal quality audits and acted as lead auditor.  Michelle served as liaison between customers and suppliers on quality related issues, performing supplier audits to maintain the integrity and development of the supply chain.

More recently, Michelle has worked as Operation Project Coordinator at PharmaLogic to develop and implement a quality system compliant with FDA regulations and ISO 13485 for medical devices.  She served as Management Representative responsible for certification and maintenance of the QMS, internal audits, CAPAs, and managing external audits.

Laboratories

At Dyna-Mix, Michelle managed the incoming and outgoing laboratory and personnel, along with employee selection and training. Her responsibilities included the testing and disposition of mixed rubber, and maintaining lab calibrations and records. She tracked and initiated action to prevent the occurrence of any nonconformities relating to the product and determined acceptance criteria using SPC methods.