Insight Global
Pleasant Prairie, WI, USA
Job Description The Document Manager is responsible for developing, organizing, and maintaining controlled documentation across Operations, Quality, and Engineering functions. This includes Standard Practices (SP), Standard Operating Procedures (SOP), and Standard Operating Controls (SOC) to ensure compliance with regulatory requirements and internal quality standards for a medical device manufacturer. Key Responsibilities Document Development & Maintenance ? Create, review, and update SPs, SOPs, SOCs, and other controlled documents. ? Ensure documents meet regulatory standards (FDA, ISO 13485) and internal quality requirements. Compliance & Governance ? Maintain document control systems in alignment with Good Documentation Practices (GDP). ? Support audits by providing accurate and current documentation. Collaboration ? Work closely with Operations, Quality Assurance, and Engineering teams to capture technical processes...


