Document Control Coordinator

Job Description

Job Description

PRIMARY OBJECTIVE:

Maintains the Quality System Documentation, including procedures for document creation, review, approval and archiving. Tracks and controls documents throughout their lifecycle, ensuring proper versioning, access control, and security. Sustaining the Change control process through the internal ERP system.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

*Ensure all documents adhere to regulatory requirements, quality standards, and internal procedures.

*Scan, organize, and maintain both physical and digital documents, including archiving historical records.

*Manage users access, permissions, and system integrity within the internal ERP Change Control system.

*Schedules weekly and/or emergency CCB meetings as requested by internal departments.

*Review documents for formatting, compliance, and version control standards.

*Collaborate with cross-functional teams to facilitate document workflows, resolve issues, and ensure consistency in documentation practices.

*Maintain record retention timelines, ensuring documentation is assessable in a timely manner for internal and external audits.

*Process approved change controls in a timely manner, this includes updating information in the internal ERP systems

*Maintain internal Viewing System by adding current versions of controlled documents and removing historical revisions.

REQUIRED QUALIFICATIONS: The requirements listed below represent the knowledge/education and skill/experience required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

*Minimum two years or related experience in Document Control or Record Management preferred

*Experience with electronic document management systems preferred

*Experience in a Regulatory Medical Device Industry preferred

*Good understanding of Good Documentation Practice, (GDP), Good Manufacturing Practice, (GMP), Code of Federal Regulations Section 820.40 (Document Control), and ISO 13485:2016 Section 4.2.3, (Medical Device File/Medical Device Records, 4.2.4 (Control of Documents), and 4.2.5, (Control of Records) preferred.

*Ability to problem-solve, often cross-functionally and with various departments and levels of employees.

*Computer application skills, e.g., Microsoft Office, Word, Excel, Outlook

*Ability to read and interpret engineering drawings