Job TitleJob Responsibilities: Initiates, processes, and implements production change orders (PCO). Ensures documentation meets the requirements of divisional and local site procedures and provides guidance for improvements to the documentation systems. Maintains item master and product structure database. Notifies employees of new and changed products. Trains and educates other employees on proper documentation practices. Creates and maintains production routings for the production floor. Maintains neat and orderly work area to ensure efficiency and no safety hazards. Responsible for adhering to and implementing the requirements defined by the divisional document control procedures. Responsible for obtaining required signatures to complete requested document changes. Ensures departments receive the current specifications required. This position is required to assure compliance of company operations to all applicable laws, regulations, and standards, good business practices, and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations, and statutes related to the site). Assist with international/domestic certs. Host new-hire orientation. Second review for incoming inspection. Assist with RMA review.Required QualificationsSecondary required (high school) required.
Education requirements can be obtained through an educational institution or gained through equivalent work experience.Technical Knowledge and Skills RequiredOne to two years of technical college education preferred. Minimum of five years of data entry and documentation control experience preferred. Through understanding the drafting and document control system. Excellent knowledge of manufacturing resources planning databases as it relates to documentation. Strong verbal and written communication skills. Proficient with spreadsheet and word processing software applications.Other RequirementsAbility to communicate with all levels of employees and the management team. Detail oriented for consistent and accurate processing of documentation and production change orders. Ensure compliance with internal and external standards. Must maintain a good working relationship with all department supervisors and managers. Provides documentation as required to any other Smith Medical sites. Maintain working relationships with off-site documentation coordinators. Maintain a good working relationship with external and internal quality system auditors.Planning and Decision MakingResponsible for the maintenance of complete, concise history records of all products and related procedures. Reviews and signs of the final version of requested changes once approved. Ensures archived documentation file system is maintained for timely document retrieval.