Production QA Engineer — ISO/FDA Quality Systems Lead

North American Production Sharing de México, S.A. de C.V.; Tijuana; On-site; MXN 420,000 - 520,000; Full time

Benefits offered by this job

Weekly pay

Labor law benefits in Mexico

Savings fund

Major Medical Insurance (SGMM)

Life insurance

Grocery vouchers

Additional benefits

Job summary

North American Production Sharing de México, S.A. de C.V. is seeking a Production QA Engineer to oversee quality systems at the Tijuana facility. The role covers NCMRs, CAPA, change controls, and part-number generation, ensuring regulatory compliance.

The ideal candidate has a Bachelor's degree with 5+ years in Quality, strong knowledge of ISO 13485 and FDA requirements, and advanced English. The position involves collaboration across departments and direct support for regulatory inspections.

Qualifications

• Bachelor's degree required.
• Minimum 5 years in Quality.
• Knowledge of ISO 13485, 21 CFR Part 820, ISO 14971.
• Advanced English proficiency.

Responsibilities

• Maintain quality systems at the Tijuana plant, including NCMRs, CAPA, COR, and deviations.
• Manage part number generation for semi-finished and finished products; maintain the MVP.
• Identify deficiencies and implement improvements in quality system processes.
• Support regulatory inspections by FDA and international regulators.
• Support rework activities and define inspection and quality controls.
• Coordinate Quality Control resources across manufacturing processes and overtime.

Skills

Quality engineering knowledge

Regulatory compliance awareness

Attention to detail

Education

Bachelor's degree

Tools

Microsoft Office

Job description

North American Production Sharing de México, S.A. de C.V. is seeking a Production QA Engineer to oversee quality systems at the Tijuana facility. The role covers NCMRs, CAPA, change controls, and part-number generation, ensuring regulatory compliance.

The ideal candidate has a Bachelor's degree with 5+ years in Quality, strong knowledge of ISO 13485 and FDA requirements, and advanced English. The position involves collaboration across departments and direct support for regulatory inspections.