The Document Control Coordinator

The Document Control Coordinator plays a key role in maintaining the company’s Quality System Documentation. This includes overseeing document creation, review, approval, archiving, and change control processes within the internal ERP system. The role ensures that all documentation complies with regulatory standards and internal protocols.

Essential Duties and Responsibilities:

• Ensure documentation complies with regulatory, quality, and internal standards

• Scan, organize, and archive both physical and digital records

• Manage user access and permissions within the ERP Change Control system

• Schedule weekly and emergency Change Control Board (CCB) meetings

• Review documents for formatting, compliance, and version control

• Collaborate across departments to streamline document workflows

• Maintain record retention timelines for audits

• Process approved change controls and update ERP systems accordingly

• Maintain internal Viewing System with current document versions

Required Qualifications:

• Minimum 2 years of experience in Document Control or Record Management (preferred)

• Familiarity with electronic document management systems

• Experience in a regulated medical device industry (preferred)

• Knowledge of GDP, GMP, CFR 820.40, and ISO 13485:2016 standards

• Strong problem-solving skills across departments and levels

• Proficiency in Microsoft Office (Word, Excel, Outlook)

• Ability to read and interpret engineering drawings

Pay Range: $22 – $25/hour (based on education and experience)

Schedule: Monday–Friday, 8:00 AM – 4:30 PM

Employment Type: Temp-to-Hire