Manager, eQMS Program (Pre-Identified Candidate)

Job description

Quality Systems Manager, Medical Devices As a Quality Systems Manager, you will lead the design, implementation, and continuous improvement of electronic Quality Management Systems (eQMS). This role is accountable for ensuring quality and regulatory compliance within the eQMS platform to support Cardinal Health. The role partners closely with IT, Engineering, PMO, Quality, Regulatory, Legal, and Product teams to ensure quality is operationalized across the organization and supports rapid innovation and scale. Key Responsibilities: This Quality Systems Manager role is primarily responsible for oversight and governance of the eQMS systems which includes development, implementation, maintenance, and continuous improvement of the Quality Management Systems used to support our programs and ensuring sustained compliance with 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, EU MDR and any other applicable regulations and standards. Establish eQMS governance, decision rights, and escalation mechanisms to ensure consistent execution across products, programs, and geographies. Support internal audits, external audits, regulatory inspections, and management reviews. The role partners cross-functiona...