Quality Systems Specialist - Document Control

Join our Belfast team as a Quality Systems Specialist - Document Control

**Position Summary:**

The Document Control Specialist is responsible for managing, organizing, and maintaining controlled documents to ensure compliance with FDA regulations, ISO 13485, and company quality management system (QMS) requirements. This role supports cross-functional teams by ensuring accurate documentation, proper version control, and timely distribution of quality and regulatory documents within a fast-paced medical device environment.

**Key Areas of Responsibility:**

+ Administer the company’s document control system, including creation, revision, review, approval, distribution, and archival of controlled documents.
+ Ensure compliance with ISO 13485, 21 CFR 820, 21 CFR Part 11, and other applicable regulatory standards for medical devices.
+ Manage documents and document changes throughout document lifecycle within electronic documentation system, including...