Document Manager

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 u2003u2022 Document Development & Maintenance u2003u2003u25cb Create, review, and update SPs, SOPs, SOCs, and other controlled documents. u2003u2003u25cb Ensure documents meet regulatory standards (FDA, ISO 13485) and internal quality requirements. u2003u2022 Compliance & Governance u2003u2003u25cb Maintain document control systems in alignment with Good Documentation Practices (GDP). u2003u2003u25cb Support audits by providing accurate and current documentation. u2003u2022 Collaboration u2003u2003u25cb Work closely with Operations, Quality Assurance, and Engineering teams to capture technical processes accurately. u2003u2003u25cb Facilitate document reviews and approvals through established workflows. u2003u2022 Training & Support u2003u2003u25cb Train staff on document control processes and ensure adherence to documentation policies. u2003u2022 Continuous Improvement Identify opportunities to streamline documentation processes and improve efficiency. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements u2022 Bacheloru2019s degree in Engineering, Quality Management, or related field. u2003u2022 5+ years of experience in document control or technical writing within a regulated industry (medical devices preferred). u2003u2022 Strong knowledge of FDA regulations, ISO standards, and GDP. u2003u2022 Proficiency in document management systems (e.g., IQMS MasterControl, Veeva). u2003u2003u25cb 2+ years of experience with IQMS strongly preferred u2003u2022 Excellent attention to detail and organizational skills. - Experience leading tech transfer from one GMP/ISO regulated site to another - Experience with change control processes. - Familiarity with risk management and CAPA documentation. - Strong communication skills for cross-functional collaboration.

Created: 2025-12-15