Quality Engineer

TekniPlex; Ciudad Juárez; On-site; MXN 300,000 - 460,000; Full time

Job summary

TekniPlex is seeking a Quality Assurance professional to develop, implement, maintain, and improve QA processes. The role emphasizes data analysis to understand quality reporting and drive process improvements.

You will support the Quality Supervisor and Inspectors in ensuring GMP compliance and product quality across manufacturing operations. Responsibilities include problem identification, root cause analysis, and leading continuous improvement initiatives, as well as participating in audits

Qualifications

• Bachelor's degree in Mechanical, Electrical, or Manufacturing Engineering.
• 4+ years' of industry experience in medical devices.
• Analytical and quantitative approach to problem solving.
• Strong knowledge of quality tools used in the medical devices industry.

Responsibilities

• Support the Quality Supervisor and Quality Inspectors.
• Ensure Good Manufacturing Practice guidelines are followed.
• Make decisions about Product Quality and coordinate with Production to ensure specifications are met.
• Perform problem identification, resolution, and continuous improvement.
• Develop and analyze quality reporting measures.
• Participate in internal and external quality audits.
• Provide customer service related to quality concerns.

Skills

Analytical thinking

Quantitative analysis

Education

Bachelor's degree in Mechanical, Electrical, or Manufacturing Engineering

Job description

This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.

Responsibilities

• Responsible for supporting the Quality Supervisor and Quality Inspectors.
• Ensure that Good Manufacturing Practice guidelines are followed.
• Responsible for making decisions about Product Quality.
• Responsible for properly following up with the Production Department to ensure compliance and adherence to product specifications, as well as making sure the product is built according to the Work Instructions.
• Perform problem identification, resolution, loss reporting and continuous improvement
• Develop, execute, and analyze quality reporting measures
• Participate in internal and external quality audits
• Customer Service

Qualifications

• Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
• 4+ years' of industry experience in medical devices
• Strong knowledge of quality tools used in the medical devices industry
• Analytical and quantitative approach to problem solving