Global QMS Documentation & Records Control Specialist II

We Make Life More Rewarding and Dignified 

Location: ​Libertyville​
Department: ​Quality 

 

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.

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

• Communicate effectively via email, phone, and virtual platforms.
• Collaborate across departments to support organizational goals.
• Participate in cross-functional meetings and initiatives.
• Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
• Prepare reports and dashboards for internal stakeholders.
• Ensure data accuracy and confidentiality in compliance with company and legal standards.
• Manage multiple priorities and deadlines in a fast-paced environment.
• Lead or support special projects aligned with departmental objectives.
• Demonstrate initiative in identifying process improvements or automation opportunities.
• Serve as a point of contact for internal and external stakeholders.
• Resolve inquiries and issues with professionalism and discretion.
• Maintain secure handling of sensitive information.
• Support audits and regulatory reporting as needed.

Education & Work Requirements

• Bachelor's Degree with 2-5 years of related experience

Education & Work Preferences

• Experience with an eDMS (e.g., Veeva Vault, Master Control,