**Detailed daily activities**
Review new and modified processes.
- Analysis for validation or revalidation requirements (IQ/OQ/PQ).
- Validation protocols creation.
- Validations tracking.
- Support on validation corrective actions required.
- Report validation results.
Statistical support on production processes
- Required SPC tool evaluation.
- Report validation results.
- Capability studies implementation.
- Gage R&R; implementation.
- Support to implement methods/altern sampling.
- Support to eliminate destructive tests.
- Support to improvement projects.
**Job Requirements**:
**Experience**
- Industrial Engineer, Mechanical Engineer, Electronics Engineer, or similar.
- Medical Industry Experienced.
- QMS and ISO Standard Knowledge (ISO13485 and/or FDA GMP)
- Manufacturing Process 3-year-experienced
- New Product development/Process transfers/Process improvement experienced.
- English about 85% Preferred (spoken, written, read)
**Operating Company**:
Ormco

📌 Quality Engineer (Mexicali)
🏢 Envista Holdings
📍 Mexicali