Documentation Coordinator I

The Documentation Coordinator I will be responsible for maintaining the document control process, which includes making document changes, routing for review and approval, making documents effective, distributing documents and making notifications. In addition, the Documentation Coordinator I will be responsible for maintaining the training process, which includes keeping the training matrix current, routing training assignments, ensuring training has been completed and filing training records. ESSENTIAL JOB DUTIES & RESPONSIBILITIES Follow all procedures and work instructions defined in the Quality System Manual Documentation Review of document change orders to confirm all steps have been completed Process, implement and release document change orders Maintain master documents Distribute controlled documents and remove obsolete revisions Coordinate training of revised documents Update technical files with document changes Create and/or update specifications, procedures, work instructions, forms and labels using Word and Excel in support of changes Support inspections and audits performed by FDA, Notified Body and customers Assists in compiling Design History Files Support agency listings and certifications: FDA, ISO 13485, MDSAP Support quality inspection department as needed Support manufacturing to keep product documentation accurate and up to date Support purchasing with complete documentation as required Support quality functions as needed Perform other duties as assigned by manager or supervisor EDUCATION & EXPERIENCE REQUIREMENT Must have proven attention to details and excellent organization skills Two-year degree or equivalent experience; ability to apply learned technology to Company products and processes Intermediate proficiency with Microsoft Word & Excel, Adobe Acrobat, LabelView Must possess excellent verbal and written communication skills in English, which includes the ability to read, write and speak to comprehend and execute internal procedures, drawings and Manufacturing Work Instructions (MWIs) PREFERRED SKILLS & ABILITIES Document control and medical device industry a plus Ability to understand FDA 21 CFR Regulations, Good Documentation Practices, ISO 13485, MDSAP WORKING CONDITIONS & PHYSICAL DEMANDS Regularly sit at a computer workstation entering data Must be able to fulfill all requirements for cleanroom access Ability to lift and move materials and product up to 35 lbs. Office or Manufacturing environment. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.