Global QMS Documentation & Records Control Specialist II

Summary

The Global QMS Documentation and Records Control Specialist is responsible for managing the end-to-end lifecycle of controlled documents and quality records. This involves ensuring that the control of quality procedures and records complies with all applicable global requirements/standards (e.g., FDA QMSR, ISO 13485). This role is essential for ensuring that medical device products are designed, manufactured, and maintained to validated specifications every time and maintaining audit/inspection readiness.

Responsibilities

Change Control Management: Coordinate the review, approval, and release of new or revised documents (e.g., GPDs, WIDs, drawings, specifications) via the electronic Document Management System (eDMS).

Quality Record Maintenance: Audit and archive critical QMS documents and records, including Internal Audit Records, External Inspection Records, Approved Supplier Records, etc. to ensure they are properly retained and made available, as necessary.

Audit & Inspection Support: Act as a primary point of contact for document retrieval during internal audits and external regulatory inspections (e.g., FDA, Notified Bodies).

Training Administration: Link released documents to training requirements ensuring timely assignment of training requirements to associates.

Good Documentation Practices (GDP): Enforce GDP across the organization, identifying and correcting errors in metadata, templates, signatures, and versioning.

• Archival & Retention: Manage physical and electronic archives, overseeing retention schedules and secure off-site storage through approved vendors (e.g., Iron Mountain).
• Process document changes and track approval workflows
• Work with internal stakeholders to collect, distribute and update required documents as required
• Provides reports and metrics regarding the performance of document control management
• Supports driving continues improvement regarding the document control process and system
• Supports investigation and driving corrective actions regarding the document control process
• Maintenance of the Approved Vendor List
• Other duties as assigned

Essential Functions of the Role

Education & Work Requirements

Education & Work Preferences

• Experience with an eDMS (e.g., Veeva Vault, Master Control, etc.)
• Strong understanding of document control in the medical device industry
• Strong understanding of applicable standards (e.g., FDA QMSR, ISO 13485, ISO 14971)
• Experience in regulated environments; medical device industry is highly desirable.
• Proficiency in Microsoft Office (specifically advanced Word formatting)
• Ability to work independently and in a focused manner
• Strong interpersonal communication and customer service skills
• Exceptional Attention to Detail: Ability to spot a missing signature or a minor typo in a multi-page document.
• Aptitude Toward Structure and Organization: Capability to manage and catalog thousands of active and archived documents and records while maintaining support of day-to-day document management needs.
• Analytical and Problem Solving Skills

Competencies