Sterilization Quality Engineer - ISO 13485 & CAPA Lead

BVI Medical; Ciudad Juárez; On-site; MXN 1,621,175 - 2,330,096; Full time

Job summary

A medical device manufacturer in Ciudad Juárez is seeking a Quality Assurance Specialist. This role involves managing the quality management system, monitoring sterilization processes, and ensuring compliance with regulatory standards. The ideal candidate will have at least 5 years of experience in Quality Assurance and a strong understanding of sterilization methods. This position offers a competitive salary ranging from $88,500 to $127,200.

Qualifications

• 5+ years of experience in Quality Assurance or 3 years with FDA QSR.
• Knowledge of manufacturing processes.
• Demonstrated ability to support and direct teams.

Responsibilities

• Support the Quality Manager in managing the quality management system.
• Monitor and review sterilization processes and external testing.
• Ensure compliance with ISO standards and regulatory inspections.
• Lead CAPA investigations and continuous improvement initiatives.

Skills

Strong understanding of sterilization methods

Problem-solving techniques (lean, DOE, statistical analysis)

Experience in Quality Assurance

Proven techniques for process improvement

Education

Bachelor's degree in science or engineering

Master's degree in sciences

Job description

A medical device manufacturer in Ciudad Juárez is seeking a Quality Assurance Specialist. This role involves managing the quality management system, monitoring sterilization processes, and ensuring compliance with regulatory standards. The ideal candidate will have at least 5 years of experience in Quality Assurance and a strong understanding of sterilization methods. This position offers a competitive salary ranging from $88,500 to $127,200.