Quality Engineer

Manage and execute assigned quality projects to meet quality assurance objectives within an FDA compliant Title 21 section 820 environment. Create and update quality system procedures, evaluate product changes, and direct disposition through the change control system. Assemble non-sterile products into kits, participate in equipment qualification, and create inspection models and testing requirements. Review non-conformances, interface with supplier quality representatives, and assist in inspecting work-in-progress and finished assemblies. Drive continuous improvement and lean culture across the organization.