Senior Quality Systems Engineer
Core
Senior Quality Systems Engineer leading material controls processes, supplier quality, and regulatory compliance for medical devices.
Role type
Senior Quality Systems Engineer (Material Controls)
Builds
Global material controls processes, supplier qualification, and corrective action systems
Domain
Medical Device Manufacturing / Quality Systems
Required skills
Supplier Quality Management, Supplier Engineering, Sourcing, Medical Device Regulations, FDA Compliance, ISO 13485, CAPA Management, Supplier Audits, AVL Management, Material Qualification, Process Improvement
Preferred skills
Project Management, Cross-functional Leadership, Global Sourcing Strategy, Community of Practice Leadership
Technologies
None stated
Responsibilities
Lead cross-functional projects to coordinate activities and meet timelines, assess material controls processes for regulatory compliance, own global systemic CAPAs, guide teams on supplier audit/AVL and material qualification, track material controls metrics and trends, participate in global Communities of Practice, support site and global CAPA initiatives.
Seniority
Senior, hands-on IC