SUMMARY: Leads the organization in the areas of initiation, maintenance, traceability and continuous improvement of all manufacturing documents and supporting systems. Acting as a stable reference point, the operations engineer ensures that personnel across all departments and shifts have access to information to allow them to follow the same protocols.
In particular this function includes responsibility for the overall structure of on the floor documentation as well as responsibility for ensuring the accuracy and accessibility of the information. Work with production personnel to understand needs and provide clear and concise documentation that aide in the manufacture of safe and compliant devices.
Continuously improve the administration and timely execution of deviations (DEV), engineering change order (ECO) and engineering request (ER) activity. Provide a structured plan and work toward execution of that plan to move the organization to a paperless environment including work orders, routings, work instructions etc.
Work in conjunction with the Quality Assurance and Regulatory groups to ensure that we are in full compliance and we are adapting and improving our processes as requirements change. Install, maintain and/or adapt a documentation system that allows for traceability of all applicable piece parts. Enable a quick and efficient means of qualifying production parts purchased from alternative sources. Establish a traceable system that allows for multiple supplier sources of a production parts while maintaining their traceability.
The role would require day to day work assignment for some production personnel
Education and Experience:
Bachelor's degree in Industrial Engineering or closely related field
5+ years’ experience in a highly regulated manufacturing environment is preferred
Must be legally authorized to work in the United States without company sponsorship.