Quality Assurance Document Manager

Primary Objective

The Document Control Coordinator is responsible for managing and maintaining the Sechrist Quality System documentation to ensure full compliance with regulatory requirements and internal standards. This role involves overseeing the creation, review, approval, and archiving of documents, tracking updates and changes, and maintaining version control. The position also involves sustaining the Change Control process within the company's ERP system to support operational and quality system requirements.

Key Responsibilities

• Ensure all quality system documents comply with regulatory standards, internal policies, and formatting guidelines.
• Organize, scan, and maintain both physical and electronic documents, while archiving historical records for future reference.
• Administer user access, permissions, and system integrity within the ERP-driven Change Control system.
• Schedule and coordinate weekly or emergency Change Control Board (CCB) meetings as requested by internal teams.
• Review documents to ensure they meet formatting, compliance, and version control standards before approval and distribution.
• Collaborate with cross-functional teams to facilitate document workflows, address issues, and promote consistent documentation practices.
• Monitor and comply with record retention policies, ensuring timely access to documentation for internal and external audits.
• Process approved change controls efficiently, including updating information and coordinating changes in the ERP system.
• Maintain the internal Viewing System by uploading current versions of controlled documents and removing outdated revisions.

Required Qualifications

• Experience: Minimum 2 years of experience in document control, records management, or a similar role (preferably in a regulated or medical device industry).
• Technical Knowledge: Familiarity with electronic document management systems. Solid understanding of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and relevant regulatory standards (e.g., CFR 820.40, ISO 13485:2016).
• Skills: Problem-solving and cross-functional communication skills. Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Ability to read and interpret engineering drawings.
• Preferred Skills: Knowledge of document control systems or processes specific to the medical device industry.