Production QA Engineer – ISO/FDA Compliance & Quality Ops

North American Production Sharing, Inc.; Tijuana; Presencial; MXN 469.000 - 670.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Weekly pay

Grocery vouchers

Major Medical Insurance (SGMM)

Life insurance

Savings fund

Additional benefits

Descripción de la vacante

North American Production Sharing, Inc. in Tijuana, Mexico is seeking a Production QA Engineer to evaluate, maintain, and improve Quality Systems at the plant, including NCMRs, CAPA, and Change Control.

The role focuses on part number generation, MVP maintenance, regulatory compliance with ISO 13485, 21 CFR Part 820, COFEPRIS, and supports regulatory inspections; requires a bachelor's degree, 5+ years in quality, and advanced English.

Formación

• Bachelor's degree required.
• Minimum of 5 years of experience in Quality.
• Knowledge of Quality Engineering functions and standards.

Responsabilidades

• Maintain quality systems at the Tijuana plant, including NCMRs, CAPA, Change Orders and deviations.
• Manage part number generation for semi-finished and finished products; maintain MVP.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, COFEPRIS and other regulatory requirements.
• Support regulatory inspections and rework activities; define inspection and quality controls.
• Collaborate across manufacturing processes to coordinate Quality Control resources and overtime.

Conocimientos

Advanced English

Quality engineering knowledge

Computer skills

Educación

Bachelor's degree

Herramientas

Microsoft Office

Excel

Word

PowerPoint

Descripción del empleo

North American Production Sharing, Inc. in Tijuana, Mexico is seeking a Production QA Engineer to evaluate, maintain, and improve Quality Systems at the plant, including NCMRs, CAPA, and Change Control.

The role focuses on part number generation, MVP maintenance, regulatory compliance with ISO 13485, 21 CFR Part 820, COFEPRIS, and supports regulatory inspections; requires a bachelor's degree, 5+ years in quality, and advanced English.