Senior Production QA Engineer - ISO 13485 & FDA Compliance

North American Production Sharing, Inc.; Tijuana; Presencial; MXN 520.000 - 820.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Savings fund

Major Medical Insurance (SGMM)

Life insurance

Additional benefits

Labor law benefits

Descripción de la vacante

North American Production Sharing, Inc. in Tijuana is seeking a Quality Specialist to evaluate, maintain, and improve the Quality Systems at our facility.

The role focuses on NCMRs, CAPA, COR, and manufacturing deviations to ensure compliance with global regulatory standards. Responsibilities include master data like MVP and part-number generation, identifying process gaps, and supporting inspections by FDA and other regulatory bodies.

Formación

• Bachelor's degree completed.
• 5+ years of experience in Quality.
• Knowledge of ISO 13485, 21 CFR Part 820, ISO 14971 and related standards.
• Advanced English proficiency.
• Weekly pay is offered for this role.
• Benefits provided under Mexican labor laws.
• Savings fund available.
• Major Medical Insurance (SGMM).
• Life insurance.
• Additional benefits.

Responsabilidades

• Maintain quality systems at the Tijuana plant, including NCMRs, CAPA, Change Orders (COR), and manufacturing deviations.
• Manage part number generation for semi-finished and finished products. Maintain the Master Validation Plan (MVP).
• Identify deficiencies and implement improvements within quality system processes, ensuring compliance with ISO 13485, FDA regulations (21 CFR Part 820/QMSR), COFEPRIS, and other applicable regulatory requirements.
• Support regulatory inspections conducted by the FDA and international regulatory agencies.
• Support rework activities and define inspection and quality controls.
• Collaborate in coordinating Quality Control resources across manufacturing processes and overtime requirements.

Conocimientos

Quality engineering

Advanced English

Regulatory compliance

Process improvement

Educación

Bachelor's degree

Descripción del empleo

North American Production Sharing, Inc. in Tijuana is seeking a Quality Specialist to evaluate, maintain, and improve the Quality Systems at our facility.

The role focuses on NCMRs, CAPA, COR, and manufacturing deviations to ensure compliance with global regulatory standards. Responsibilities include master data like MVP and part-number generation, identifying process gaps, and supporting inspections by FDA and other regulatory bodies.