Job Description

We are partnered with a complex medical device manufacturer seeking a Document Control Specialist to join their team as they release a new product line. You will be working with the document control manager as you work through Change Controls, Trainings, and assist with eQMS implementation.

Key Responsibilities:

• Maintain and manage document control systems in compliance with ISO 13485, FDA 21 CFR Part 820 , and other applicable regulations.
• Ensure proper documentation creation, review, approval, and archival in an electronic document management system (EDMS).
• Support the administration of change control processes, ensuring proper tracking, review, and implementation of changes to controlled documents.
• Work cross-functionally with Quality, Regulatory, Engineering, and other departments to ensure timely and compliant documentation updates.
• Perform periodic audits of controlled documents to ensure compliance and accuracy.
• Assist in training employees on document control procedures and best practices.
• Support internal and external audits by providing necessary documentation and ensuring compliance with regulatory requirements.

Qualifications:

• Associate’s or Bachelor’s degree in a related field (or equivalent experience).
• 2+ years of experience in document control within a medical device, pharmaceutical, or regulated industry .
• Familiarity with ISO 13485, FDA 21 CFR Part 820, and change control processes .
• Experience working with electronic document management systems (EDMS) .

Preferred Qualifications:

• Experience with change control processes in a regulated environment.
• Knowledge of risk management principles related to documentation.
• Experience with eQMS transfer.

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