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.