Document Control Specialist

The Document Control Specialist administers and maintains the organizations document control system to ensure full compliance with medical device regulations and quality management system requirements. In this role, you ensure that controlled documents, records, and quality system documentation are accurately reviewed, approved, distributed, revised, archived, and retained in alignment with company procedures and regulatory standards, including FDA 21 CFR Part 820, FDA Quality System Regulations (QSR), ISO standards, MDSAP, and other applicable global regulations.

This position offers the opportunity to support a growing product line and gain valuable experience in the medical device industry.

• Manage the complete document lifecycle, including creation, review, approval, distribution, revision, obsolescence, and archival of controlled documents.

• Maintain both electronic and paper-based document control systems, ensuring document accuracy, completeness, and ease of accessibility.

• Process Engineering Change Orders (ECOs), Document Change Orders (DCOs), and related documentation updates in a timely and compliant manner.

• Route and secure approvals for Standard Operating Procedures (SOPs), Work Instructions, Forms, Specifications, Device Master Records (DMRs), and other quality records.

• Maintain detailed revision histories and document traceability in accordance with quality system requirements.

• Support compliance with FDA Quality System Regulations (QSR), ISO standards, MDSAP, and other applicable regulatory requirements.

• Perform periodic audits of controlled documentation to verify accuracy, completeness, and regulatory compliance.

• Coordinate document issuance and assign training related to new or revised procedures to ensure appropriate awareness and implementation.

• Maintain records retention and archival processes in line with company policies and regulatory requirements.

• Assist with internal, customer, and regulatory audits by providing requested documentation, records, and evidence of compliance.

• Support Corrective and Preventive Actions (CAPA), Nonconformance Reports (NCR), Risk Management files, and other quality system records through accurate documentation management.

• Track and report document control metrics, including approval cycle times, overdue reviews, and current document status, to support continuous improvement.

• Collaborate closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations teams to ensure documentation accurately reflects current processes and practices.

• Ensure document templates, numbering systems, and formatting standards are consistently applied across all controlled documents.

• Participate in continuous improvement initiatives focused on enhancing quality system documentation and document management processes.

• Perform data entry and quality control checks on documentation to maintain high standards of accuracy and integrity.

• Associate's degree in Business Administration, Life Sciences, Engineering, Quality, or a related field; a Bachelor's degree is preferred.

• Minimum of 2 years of document control experience in a regulated industry.

• Experience in the medical device, pharmaceutical, biotechnology, or healthcare industry is strongly preferred.

• Knowledge of FDA 21 CFR Part 820, FDA Quality System Regulations (QSR), ISO standards, MDSAP, and Good Documentation Practices (GDP).

• Hands-on experience with Electronic Document Management Systems (eDMS), such as Master Control, ETQ, Veeva, Arena, or similar platforms.

• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.

• Strong organizational skills with exceptional attention to detail and…