Document Control Specialist

About the role

The Document Control Specialist administers and maintains the company’s document control system to ensure full compliance with medical device regulations and quality management system requirements. This role supports a growing product line and gains valuable experience in the medical device industry.

Responsibilities

• 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 easy accessibility.
• Process Engineering Change Orders (ECOs), Document Change Orders (DCOs), and related documentation updates in a timely and compliant manner.
• Ensure prompt routing and approval of 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), Good Documentation Practices, MDSAP, and other applicable regulatory requirements.
• Perform periodic audits of controlled documentation to verify accuracy, completeness, and regulatory compliance.
• Cook up document issuance and associated training assignments for new or revised procedures, ensuring relevant personnel are informed and trained.
• Maintain records retention and archival processes in line with company policies and regulatory requirements.
• Absorb coordination with internal, customer, and regulatory audits by locating, preparing, and providing requested documentation and records.
• Support quality system activities including Corrective and Preventive Actions (CAPA), Nonconformance Reports (NCR), Risk Management files, and other quality records.
• Track and report document control metrics such as approval cycle times, overdue reviews, and document status to support continuous improvement.
• Collaborate closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations teams to ensure documentation accurately reflects current processes.
• Ensure document templates, numbering systems, and formatting standards are consistently applied across all controlled documents.
• Participate in continuous improvement initiatives related to quality system documentation and document management processes.
• Provide accurate data entry and quality control support to maintain high standards of documentation integrity.

Requirements

• Associate’s degree in Business Administration, Life Sciences, Engineering, Quality, or a related field.
• Minimum 2 years of document control experience in a regulated industry.
• Experience in the medical device, pharmaceutical, biotechnology, or healthcare industry strongly preferred.
• Experience working in a medical device or other highly regulated industry.
• Knowledge of FDA 21 CFR Part 820 and Good Documentation Practices (GDP).
• Experience with Electronic Document Management Systems (eDMS) such as MasterControl, 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.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Thorough understanding of document control principles and records management.
• Ability to maintain confidentiality and protect data integrity.
• High level of accuracy and a strong commitment to quality.
• Strong quality control and data entry skills.

Qualifications

• Bachelor’s degree in Business Administration, Life Sciences, Engineering, Quality, or a related field.
• Experience supporting FDA inspections, ISO audits, or MDSAP audits.
• Working knowledge of change control, CAPA, risk management, and quality system processes.
• ASQ or other quality-related certifications.
• Familiarity with medical device quality systems and regulatory expectations.
• Strong analytical and problem-solving skills.
• Customer service orientation and the ability to work effectively with cross-functional teams.
• Interest in contributing to a growing product line and expanding experience in the medical device industry.

Skills

• Associate’s degree in Business Administration, Life Sciences, Engineering, Quality, or a related field.
• Experience supporting FDA inspections, ISO audits, or MDSAP audits.
• Working knowledge of change control, CAPA, risk management, and quality system processes.
• ASQ or other quality-related certifications.
• Familiarity with medical device quality systems and regulatory expectations.
• Strong analytical and problem-solving skills.
• Customer service orientation and the ability to work effectively with cross-functional teams.
• Interest in contributing to a growing product line and expanding experience in the medical device industry.