Quality

Job Summary:

The QA/QC Documentation Specialist is responsible for maintaining and managing quality-related documentation to ensure compliance with regulatory standards in a medical equipment manufacturing environment. This role supports the Quality Assurance and Quality Control teams in the preparation, review, and control of documentation that ensures consistent product quality and regulatory compliance.

Key Responsibilities:

• Maintain and update Quality Management System (QMS) documentation, including SOPs, work instructions, quality manuals, forms, and logs.
• Review and process quality documentation such as batch records, device history records (DHRs), calibration logs, and validation reports.
• Ensure all controlled documents are accurate, up-to-date, properly archived, and accessible as per internal policies and regulatory requirements.
• Assist in document change control processes, including initiation, tracking, and implementation of document revisions.
• Support internal and external audits by organizing and presenting required quality documentation.
• Coordinate with cross-functional teams (production, engineering, regulatory affairs, etc.) to gather documentation and ensure timely updates.
• Monitor and report document compliance issues or deviations and help initiate corrective actions.
• Train staff on documentation control procedures and compliance requirements as necessary.