Document Control Associate

SUMMARY

The Document Control Associate is responsible for maintaining the integrity of the Quality Management System (QMS) in a regulated medical device manufacturing environment. This role ensures Quality System documentation is accurate, current, properly approved, and distributed in compliance with applicable regulations. The ideal candidate is detail-oriented, thrives in process-driven work, and is committed to long-term growth within a compliance-focused team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Distribute documents for revision to appropriate users and remove obsolete documents within the QT9 eQMS or shared server.

• Maintain “Master” and electronic files of Quality System documentation in QT9 or on shared server.
• Ensure change control compliance by reviewing completeness, accuracy, and proper document approval of all quality system records.
• Confer with document originators and approvers collaboratively to prepare controlled documents conforming to company format and standards.
• Help create and revise quality system documents as required.
• Notify all affected departments of document changes and effective dates.
• Perform duties as defined in document control policies and procedures.
• Perform scanning and filing of documentation as required.
• Communicate clearly with all personnel to ensure document routings and distributions are handled in a timely fashion.
• Support rework, deviations, and nonconformance processes by assigning numbers, completing QAD tasks, and reviewing documentation for correctness.
• Maintain records regarding the status of all document and change control processes.
• Send out training in QT9 eQMS for new and revised documents. 

QUALIFICATIONS:

• Exceptional attention to detail with the ability to identify errors, inconsistencies, and non-conformances in documentation.
• Demonstrated ability to follow written procedures precisely with minimal deviation.
• Ability to adapt to change and work flexibly in an active, sometimes high-traffic environment.
• Proficiency in computer applications required to execute assigned tasks (Outlook, MS Word, MS Excel).

EDUCATION and/or EXPERIENCE

• Associate’s or Bachelor’s degree from an accredited college or university is required.
• 1–3 years of experience in document control, records management, quality administration, or a related administrative role in a regulated industry is preferred.
• Prior experience in medical device, pharmaceutical, or other FDA-regulated manufacturing environment is a strong plus.
• Experience with an electronic Quality Management System (eQMS) such as QT9, MasterControl, Veeva, or equivalent is a plus.
• Equivalent combination of education and experience will be considered.

QUALITY COMMITMENT

This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

WORK ENVIRONMENT

Employee works in a typical office environment within a medical device manufacturing facility. Must be able to reach and file all types of documentation, including small files, large binders, and archive boxes. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EQUAL OPPORTUNITY EMPLOYER PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law. 

STATEMENT of OTHER DUTIES DISCLAIMER

This Job description in no way states or implies that these are the only duties to be performed by this employee. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.