The Document Control Specialist manages and maintains quality-related documentation, including SOPs and work instructions. This role ensures compliance with regulatory standards, oversees version control, and facilitates communication and training on document changes. The Specialist supports internal and external audits, utilizes Electronic Document Management Systems, and collaborates across departments to ensure the organization's adherence to quality management practices.
• Manage the Document Change Order (DCO) Process for the release, approval, distribution, maintenance, retrieval, and storage of quality system documents and records per the company's Standard Operating Procedures.
• Support the Change Control Board (CCB) to process DCOs, implement changes, complete product disposition, and complete all DCO activities in a timely manner.
• Maintain and support compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations.
• Manage the employee training program and maintain the training matrix by working with the hiring managers to ensure current training records, job description, and employee records are incompliance with company's Standard Operating Procedures.
• Maintain control of electronic and hard copy of documents for SOPs, product specifications and drawings, inspection and manufacturing procedures, clinical documentation and protocols, process validation, design control, marketing and educational material and test reports.
• Maintain and update Master Document List and Document Change Control Logs to ensure consistency and record keeping.
• Support and Maintain Design History Files, Regulatory Technical files, Device Master Records, and other Design Dossier documents.
• Assist with internal audits in compliance with the company's internal audit procedure
• Maintain the quality systems databases to provide quality metrics data on routine basis or as required.
• Prepare quality system trending information and prepare data summaries for management review meetings and other similar meetings as needed
• Assists the Management Representative during external audits (FDA), Notified Body, California State Department of Public Health)
• Support the Head of QA/RA during product development projects to ensure compliance and regulatory requirements are met throughout the development process.
• Support the Head of QA/RA during regulatory submissions, responses, and communication with regulatory agencies such as the FDA and Notified Body.
• High school diploma or equivalent.
• 2+ years of experience in biotech or medical device.
• Knowledge in document control change process, quality assurance, and ISO 13485 Quality Management System.
• Knowledge of medical device regulations and good manufacturing practices.
• Attention to detail and a focus on continuous improvement.