Quality Engineer

Operating Company: Spark
Location: Mexicali,Baja California,MX
Date Posted: July 23, 2024
Req Number: R5020424

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.
- Suport 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**:
Spark