Document Control Specialist

Job Title: Document Control Specialist – Medical Device

General Purpose:
The Document Control Specialist is responsible for managing the creation, distribution, storage, and maintenance of controlled documents within a regulated medical device environment. This role ensures that all documentation, including procedures, work instructions, and forms, complies with FDA, ISO 13485, and internal Quality Management System (QMS) requirements.

Key Responsibilities:

Administer and maintain the Quality Management System (QMS) documentation in compliance with FDA 21 CFR Part 820 and ISO 13485 standards.

Ensure controlled documents are properly authored, reviewed, approved, released, and archived in accordance with document control procedures.

Manage document change requests, ensuring revisions are tracked, reviewed, and implemented effectively.

Support QMS Management Reviews, including meeting preparation, minute-taking, and follow-up of action items.

Support internal and external audits (ISO, FDA, Notified Body) by ensuring document readiness and traceability.

Maintain and issue document and part numbers; track document revision history, approval status, and effective dates.

Verify document release packages for accuracy, completeness, and compliance with internal requirements.

Oversee records control activities, ensuring proper retention, retrieval, and disposal of quality records.

Develop and improve document and configuration control processes to increase compliance and efficiency.

Serve as the primary document control contact for assigned projects or cross-functional teams.

Develop and report on document control metrics to evaluate system performance.

Provide training, guidance, and support to Quality Compliance Coordinators and other personnel on document control procedures.

Qualifications:

Bachelor’s degree or equivalent experience in Quality, Life Sciences, Engineering, or a related field.

2+ years of document control experience within an FDA-regulated medical device or pharmaceutical environment.

Strong understanding of ISO 13485, FDA 21 CFR Part 820, and applicable document and records management requirements.

Experience with electronic document management systems (EDMS) such as MasterControl, Veeva, or Agile preferred.

Excellent attention to detail, organizational, and communication skills.

Ability to manage multiple priorities and work effectively in a cross-functional team environment.

Proficient in Microsoft Office and Adobe Acrobat.