Production QA Eng

Production QA Engineer

This position is responsible for evaluating, investigating, and maintaining the Quality Systems at the Tijuana facility, including Nonconforming Material Reports (NCMRs), Manufacturing Deviations, Change Control, Corrective and Preventive Actions (CAPA), and Part Number Generation.

Responsibilities:

• 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.

Requirements:

• Bachelor's degree completed.
• Minimum of 5 years of experience in Quality.
• Knowledge of Quality Engineering functions, principles, and best practices, including quality standards such as ISO 13485 , 21 CFR Part 820 , ISO 14971 , and other relevant industry standards.
• Strong computer skills, including Microsoft Office (Word, Excel, PowerPoint) .
• Advanced English proficiency.

Benefits:

• Weekly pay.
• Benefits in accordance with Mexican labor law.
• Savings fund.
• Major Medical Insurance (SGMM).
• Life insurance.
• Grocery vouchers.
• Additional benefits.

Location: Pacifico Industrial Park, Tijuana, Baja California, Mexico.