Incoming Inspection Coordinator

**Purpose**
The incoming inspection coordinator is responsible for overseeing the incoming inspection process for materials and components used in Align Technology’s manufacturing operations. This role ensures that all inspection activities comply with applicable procedures, specifications, and regulatory requirements, including FDA GMP/QSR and ISO 13485. The coordinator leads the incoming inspection team, manages inspection-related projects, and ensures that materials are evaluated and accepted in accordance with pre-established inspection plans and quality standards.
Key Responsibilities
- Ensure all incoming inspection activities comply with ISO 13485, FDA 21 CFR Part 820, and other applicable global regulatory requirements (e.g., MDSAP)
- Maintain effective communication with Align Mexico management regarding the status, performance, and outcomes of the incoming inspection process.
- Define and monitor key performance indicators (KPIs) for the incoming inspection pro...