Global QMS Documentation & Records Control Specialist II

Job description

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 reg...