Quality Specialist/ Division Quality Program Lead
Core
Lead end-to-end relabeling and remediation programs ensuring compliance with quality systems and regulatory requirements across manufacturing and distribution sites.
Role type
Division Quality Program Lead
Builds
Relabeling programs, remediation initiatives, and field action programs
Domain
Medical device manufacturing / Highly regulated industry
Deliverable
client delivery
Required skills
Cross-functional program leadership, Quality systems (NC/CAPA, change control), Regulatory compliance, Documentation development, Site readiness coordination, Logistics and inventory management, Risk mitigation
Preferred skills
Relabeling/remediation program experience, Global/multi-site operations experience, ERP systems and product traceability familiarity
Responsibilities
Lead and execute end-to-end relabeling programs from planning through completion, Drive alignment across cross-functional stakeholders on scope, timelines, and execution strategy, Ensure compliance with quality systems, regulatory requirements, and change control processes, Oversee development of key documentation (work instructions, lot records, traceability documentation), Coordinate site readiness including materials, equipment, and trained personnel, Manage logistics and inventory movement to support relabeling execution
Seniority
Mid-level, hands-on IC
