QA Document Control Specialist

The QA Document Control Specialist is responsible for managing, maintaining, and improving the organization’s document control processes to ensure compliance with applicable regulatory, quality, and industry standard such as ISO 13485 and FDA 21 CFR 820.

This role oversees the creation, revision, approval, distribution, and archival of controlled documents, ensuring accuracy, accessibility, and version control throughout the document lifecycle.

Key Responsibilities

• Maintain and control all MGC’s documents including Standard Operating Procedures, Procedural Work Instructions, forms, specifications, and records using document management system.
• Ensure proper document routing, review, approval, issuance according to internal procedures.
• Perform periodic review of controlled documents to ensure continuous accuracy and relevance.
• Assist with establishing Adobe electronic signatures for new employees or when digital ’s have expired.
• Maintain QMS logs associated with control of documents.
• Ensure adherence to record retention and archival practices.
• Support internal and external audits.
• Act as a liaison between departments to ensure clarity and consistency in documentation practices.
• Support Quality Systems Manager with monitoring CAPA System.
• Participate in quality initiatives and other assignments.
• Identify process inefficiencies within document workflows and propose enhancements.
• Transition from paper-based to electronic documentation and workflows.
• Assist the QARA team with redlines and routing of Engineering Change Orders.

• Process-oriented problem solver
• Attention to detail and accuracy
• Adaptable/Flexible with multiple priorities
• Ability to work autonomously and proactively in a regulated environment
• Effective with time management

This position has no supervisory responsibilities

• Will be required to regularly stand or sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see.
• Occasionally lift and/or move up to 25 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms.
• Requires repetitive motion and manual dexterity.
• The environment is fast paced; time pressured and requires accuracy.
• Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate.

Very limited travel (