Document Control and Quality Management Systems Specialist

Job Description:

The Document Control Specialist is responsible for managing and maintaining the company’s Quality Management System (QMS) documentation using MasterControl. This role ensures controlled documents comply with regulatory and internal requirements, maintains document lifecycle processes, and supports audits.

In addition, the position will lead and support quality improvement initiatives, utilizing data analysis, root cause analysis, and corrective/preventive actions to improve processes and product quality.

Duties and Responsibilities:

Document Control & QMS Management

1. Administer and maintain the MasterControl Quality Management System.
2. Manage the full document lifecycle including creation, review, approval, revision, and archival.
3. Ensure all SOPs, work instructions, policies, forms, and records are controlled and current.
4. Coordinate documents, review cycles and maintain revision histories.
5. Provide training and support to users on MasterControl document workflows.
6. Maintain document formatting and control standards.
7. Support audit readiness by ensuring documentation is accurate and easily accessible.
8. Track and manage document change requests and updates.
9. Optimize system set up and ease of use to improve user experience
10. Drive centralization and standardization through system usage
11. Manage and optimize license usage to maximize value for the investment

Quality Improvement & Process Optimization

1. Lead and support continuous improvement projects across departments.
2. Analyze quality data to identify trends, gaps, and improvement opportunities.
3. Collaborate with cross-functional teams to improve processes, reduce defects, and enhance compliance.
4. Prepare reports and presentations on quality performance and improvement initiatives.

Compliance & Audit Support

1. Assist with internal and external audits (regulatory, customer, and certification audits).
2. Ensure documentation supports compliance with applicable standards
3. Support audit responses and corrective actions as needed.

Supervisory Responsibilities: This role will report directly to the Quality Director, North America.