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.

Educational and Other Skills Requirements:

• Bachelor’s degree in Quality Management, Engineering, Life Sciences, Business, or related field preferred.

• 3–5 years of experience in document control or quality systems.
• Experience using MasterControl QMS or similar document management systems required.
• Experience leading quality improvement or process improvement projects preferred.

• Strong knowledge of Quality Management Systems (QMS).
• Familiarity with CAPA, change control, and document control processes.
• Experience with root cause analysis and continuous improvement methodologies (Lean, Six Sigma preferred).
• Excellent organizational and document management skills.
• Strong analytical and problem-solving abilities.
• Ability to manage multiple projects and deadlines.
• Strong communication and cross-functional collaboration skills.
• Attention to detail
• Process improvement mindset
• Regulatory compliance awareness
• Data analysis and reporting
• Project management
• Cross-functional collaboration

Preferred Qualifications

• Certification in Lean Six Sigma (Green Belt or higher).
• Experience in regulated industries (e.g., medical device, pharmaceuticals, biotech, or manufacturing).
• Experience with audit management and regulatory compliance.

Additional information:

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Closure Systems International, Inc., is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, veteran status, disability, sexual orientation, gender identity or national origin.