Quality Engineer
Core
Establish, control, and operate the quality management system for orthodontic products, including auditing suppliers, managing non-conforming products, and releasing finished goods.
Role type
Quality Engineer (Manufacturing)
Builds
Orthodontic products (brackets and wires)
Domain
Medical device manufacturing
Required skills
Quality management system operation, internal auditing, supplier auditing, non-conformance management, corrective and preventive action planning, regulatory compliance knowledge, document control, inspection operations
Preferred skills
Pharmaceutical or food manufacturing experience, medical device regulations knowledge, process management for new projects
Technologies
Quality management systems, inspection tools
Responsibilities
Lead internal audits of the quality management system, organize review and disposition of non-conforming products, assist supply chain in auditing suppliers, handle customer feedback and adverse event monitoring, approve or reject materials and release finished products, coordinate employee training on quality regulations
Seniority
Mid-level, hands-on IC