Overview
Document Control Specialist Jobs in United States at Taylor Hodson Staffing
Title: Document Control Specialist
Company: Taylor Hodson Staffing
Location: United States
Our client is hiring a Document Control Specialist to join otheir growing venture-backed company. The Quality Assurance & Regulatory Affairs team owns the quality management system that keeps our medical device products safe, compliant, and audit-ready. In this role, you’ll own the day-to-day lifecycle of controlled documents in our eQMS — routing, reviewing, releasing, and archiving SOPs, work instructions, forms, and records.
Responsibilities:
- Own the end-to-end document control process in our eQMS — intake, change request routing, review cycles, approval, release, distribution, and obsolescence — ensuring every controlled document is accurate, current, and traceable.
- Perform detailed technical review of document content prior to release — checking formatting, revision history, cross-references, defined terms, referenced records and forms, and alignment with existing procedures — and drive corrections to closure with authors.
- Administer and continuously improve the eQMS: maintain document templates and numbering conventions, manage user access and training assignments, configure and monitor workflows, and troubleshoot user issues.
- Maintain audit- and inspection-ready records, including the master document index, revision history, and training records, and directly support internal audits, supplier audits, notified body assessments, and FDA inspections by retrieving and presenting evidence on request.
- Partner with Quality, Regulatory, Manufacturing, Engineering, and Operations to keep document turnaround times short without compromising accuracy, and train document authors on control requirements and good documentation practices.
Requirements:
- 3+ years of experience in document control, quality assurance, or a comparable QMS role.
- Hands-on experience supporting a medical device quality system, or equivalent experience in another regulated industry with a clear understanding of how design, production, and quality records are controlled.
- Working knowledge of ISO 13485 and 21 CFR Part 820 document and record control requirements, including change control, revision management, and retention.
- Demonstrated proficiency with an eQMS or electronic document management system, including workflow configuration, user administration, and reporting
- Experience with 21 CFR Part 11 and electronic signature / data integrity requirements.
- Experience migrating documents into a new eQMS or leading a document remediation or harmonization effort.
