Document Control Specialist

The Document Control Specialist is responsible for processing controlled documentation as well as maintaining the controlled documentation system. This role ensures that new, revised, and obsolete documents are processed accurately and efficiently through the document change control process in accordance with company procedures, FDA Quality System Regulations, ISO standards, and other applicable regulatory requirements. Other responsibilities include configuration management, role management, document control, and/or enterprise system data entry.

The Document Control Specialist role performs document reviews for completeness, coordinates approvals, manages document metadata, and ensures timely release and distribution of controlled records. This role partners with crossfunctional stakeholders to ensure documentation remains current, compliant, and accessible. This role may also perform limited training duties as back-up to the Training Coordinator(s).

General Responsibilities

• Collaborates with cross-functional teams, including internal and external stakeholders to meet project objectives.

• Performs activities relating to the document change control system, including file maintenance, database maintenance, document assignment, document accuracy and completeness checks, document incorporation and release, document copying, and document distribution.

• Participates in programs designed to reduce the complexity of quality system processes and documentation within the bounds of meeting quality standards and regulatory requirements

• Triages internal document requests and support needs and escalates, as needed, and effectively communicates resolution in accurate and timely manner

• Performs activities relating to document transmittal or distribution to off-site locations

• Assists in the implementation of individual goals and objectives

• Supports quality initiative programs to enhance efficiency, productivity, and quality awareness

• Comply with LivaNova Quality Management System procedures and applicable regulations and standards resulting in quality records.

• Works daily with a high level of integrity and promote a diverse and inclusive workplace culture in both people and thought consistent with LivaNova values.

Minimum Qualifications

• High school diploma or GED

• EDMS for change control and documentation (e.g., SmartSolve, Veeva, etc.)

• Skilled in the use of Microsoft Office, Word, Excel, Visio, and Teams

• Excellent written and verbal communications skills including spelling and grammar

• Technical writing

• Previous experience in an FDA regulated industry

• Familiarity with best practices, documentation practices, product and processes

• High school diploma or GED is required

• Associate's degree is preferred