Global QMS Information Systems Lead

Job description

We Make Life More Rewarding and Dignified Location : ​Libertyville​: Department : ​Quality Summary: The Global QMS Information Systems Lead is responsible for leading the global strategy, implementation, and continuous improvement of the electronic Quality Management System (eQMS) and related digital systems. This involves ensuring these systems are properly designed, installed, and maintained to meet established user needs, functional specifications, and all applicable regulatory requirements (e.g., ISO 13485, GAMP 5, IEC 62304, FDA QSR, 21 CFR Part 11), minimizing risks to data integrity, product safety and efficacy, enabling data integrity, process efficiency, traceability, and global collaboration. This role has direct involvement with the introduction and maintenance of global software systems utilized to support the global QMS. Additionally, as a Quality Assurance representative, this position will support delivery of quality system software application validations (inclusive of developing and executing validation plans, protocols and testing documentation) in collaboration with IT and system owner cross functional teams to ensure effective and compliant computerized systems....