Document Control Specialist (Onsite)

Description

The Documentation Control Specialist will support continuous improvement by optimizing new and existing manufacturing processes through the creation and maintenance of standard operating procedures, document management and control, and providing project management support to the production department. 

Duties/Responsibilities: 

• Promotes and supports operational consistency through the creation, maintenance, use and adherence of standard operating procedures (SOPs). 
• Assist with document writing, updating and/or creating new SOPs, work instructions, training materials, job aids, etc. 
• Process ECOs within ERP and MES systems 
• Manages BOMS and component part libraries within ERP and MES systems. 
• Utilize existing document templates to standardize policies, SOPs, Work Instructions, and other document formats. Ensure document content includes compliance requirements, best practices, and procedural instructions for a wide variety of production operations activities. 
• Maintain periodic review timeframes in the quality management system (QMS), notify process owners of upcoming periodic review due dates, and coordinate closure of periodic reviews. 
• Acquires a working knowledge of all production processes. 
• Performs other duties as assigned. 

Requirements

• Experience with writing, development, or maintenance of SOPs and work instructions preferred. 
• Detail-oriented with strong critical thinking and organizational skills. 
• Strong troubleshooting and root cause analysis skills. 
• Basic understanding of electronic components. 
• Ability to work effectively with a diverse group of people and communicate information to obtain positive results. 
• Strong knowledge of Microsoft Office Suite. 
• Strong knowledge of ISO 13485 (essential) and other ISO related standards and FDA (QMSR) 

Education and Experience: 

• 2-year degree or higher (from an accredited school) in the Engineering field. 
• 3-5 years of directly related work experience in Manufacturing. 
• Experience in technical writing and documentation management is preferred.