Quality Document Control Specialist

Masterbiltorporated • South Bend, IN

22h

About The Position

The Quality Document Control Specialist ensures that all controlled documents and records (procedures, work instructions, drawings, forms, supplier documents, calibration records, change notices, etc.) are created, revised, approved, distributed, archived, and retired in compliance with AS9100, ISO 13485, and Masterbilt’s internal Quality Management System (QMS). This role works closely with engineering, quality, manufacturing, regulatory, and other functional teams to maintain document integrity, traceability, version control, and audit readiness. The role also includes coordinating and/or delivering training to employees on updated procedures and supporting internal and external audits.

Requirements

• High school diploma or GED required; additional training or certification in document control, quality systems, or records management preferred.
• 1–2 years (or more) of document control experience in a regulated or quality-driven environment (medical device, aerospace, precision manufacturing, etc.).
• Working knowledge of AS9100, ISO 13485, ISO 9001; familiarity with regulatory requirements (e.g., FDA QSR if applicable) is helpful.
• Experience with Document Management Systems (MasterControl, M-Files, Documentum, Windchill, SharePoint, etc.).
• Strong attention to detail, organizational skills, ability to manage multiple priorities and deadlines, good communication skills.
• Experience assisting with internal and external audits (AS9100, ISO 13485, ISO 9001), including document retrieval, audit trail preparation, and auditor interaction.
• Ability to work effectively with engineering, manufacturing, quality, regulatory, and supply chain teams.
• Ability to read and interpret engineering drawings and specifications is helpful.
• Understanding of document security, access control, and intellectual property sensitivity.

Responsibilities

• Manage the document control system (electronic and/or paper) to ensure proper version control, change control, archiving, retrieval, and obsolescence.
• Issue new controlled documents; route them for review, approval, and release in accordance with QMS procedures.
• Track document revision status, maintain logs, and monitor outstanding approvals or reviews.
• Coordinate with engineering, quality, manufacturing, regulatory, supply chain, and other departments to collect, review, and consolidate document changes, revisions, and updates.
• Ensure documents meet format, content, and QMS compliance requirements (headers, revision blocks, signatures, review cycles).
• Support and maintain the Document Change Notice (DCN), Engineering Change Notice (ECN), and Change Order processes, ensuring affected users receive new revisions and obsolete documents are removed or marked inactive.
• Maintain an archive of superseded documents; manage document retention schedules and ensure proper indexing, storage, and disposition.
• Assist with preparation, coordination, and participation in internal and external audits, including retrieval of controlled records, ensuring audit trails are intact, and providing documentation as requested.
• Monitor compliance with document review cycles, perform periodic document audits, and drive closure of nonconformities related to document control.
• Coordinate and/or deliver training sessions to employees on new or revised procedures and work instructions, ensuring proper understanding and compliance; maintain training records in alignment with QMS requirements.
• Generate metrics and reports on document control performance (e.g., outstanding approvals, late reviews, number of revisions, audit findings).
• Support configuration management of controlled drawings/models, especially in a machining or engineering environment.
• Maintain confidentiality and control over sensitive documents (e.g., customer manuals, specifications, regulatory submissions).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 51-100 employees