QA Engineer (Medical Devices)

Location: Mexicali, Baja California, Mexico

Company

hirify.global is an equal opportunity employer operating in the medical device manufacturing sector.

What you will do

• Lead and coordinate Corrective and Preventive Actions (CAPA) for customer complaints and process non-conformities.
• Analyze quality data, trends, complaints, and in-process non-conformances, and communicate findings to internal customers, suppliers, management, and corporate counterparts.
• Review processes using PFMEAs and develop plans to identify and address recurring quality issues.
• Define measurement equipment, component inspection methods, and control plans for raw-material delivery from warehouse to operations.
• Lead continuous improvement projects focused on quality improvement and cost reduction.
• Audit component storage locations and support the implementation and improvement of Good Manufacturing Practices (GMPs).

Requirements

• Bachelor’s degree in manufacturing, industrial engineering, or a related field.
• 1–3 years of quality control or quality engineering experience.
• Experience in medical devices, pharmaceutical, food, or personal care industries.
• Internal or Lead Auditor experience with ISO 13485:2016.
• Fluent English and bilingual communication ability required.
• Knowledge of Lean manufacturing and Six Sigma Black Belt or Green Belt practices.

Culture & Benefits

• Collaborative communication with peers, internal customers, suppliers, management, and corporate counterparts.
• Equal opportunity employment regardless of legally protected characteristics.