Ingeniero de Aseguranza de Calidad I

Avent, S. de R.L. de C.V.; Tijuana; On-site; MXN 240,000 - 360,000; Full time

Job summary

Avent, S. de R.L. de C.V.

is seeking a Quality Engineer to develop inspection procedures and support in-process quality and product issues affecting quality. You will train staff on new or modified inspection procedures, design sampling plans using AQL, RQL and CpK for attribute and variable data, and perform production process audits. Advanced English is required; 2+ years in quality, electronic engineering or a related field.

Qualifications

• More than 2 years of experience in the quality department.
• English: Advanced level.
• Career: Electronic Engineer or related.

Responsibilities

• Develop inspection procedures and test methods to support in-process and quality inspectors in manufacturing areas and functional testing labs.
• Coordinate and train on new or modified inspection procedures.
• Analyze and develop sampling plans to be used for inspection (using AQL, RQL, CpK for attribute and variable data).
• Carry out audits of production processes to verify compliance with procedures and process control plans.
• Participate in the Internal and External Audit program.
• Support validations of new processes, test methods, equipment, or products (IQ, OQ, PQ, TMV).

Skills

Quality Assurance

Auditing

Process Improvement

Regulatory Compliance

Training

Education

Electronic Engineer or related

Job description

Development of Quality functions and process improvements through updates and changes to the quality system. Support in the resolution of processes, production and product problems that potentially affect product quality. Promote training and regulatory compliance. Support supervision of quality personnel as required.

1. Development inspection procedures and test methods to provide support to in-process and quality inspectors in manufacturing areas and functional testing labs.
2. Coordinate and give training on new or modified inspection procedures.
3. Analysis and development of sampling plans to be used for inspection (using corresponding AQL, RQL, Cpk for attribute and variable data).
4. Carry out audits of the production processes to verify that practices and activities follow the quality requirements as it is specified in the procedures and process control plans.
5. Participate in the Internal and External Audit program.
6. Support in the execution of validations of new processes, test methods, equipment, or products (IQ, OQ, PQ, TMV).

Required Qualifications:

English: Advanced level.

Experience: More than 2 years of experience in the quality department.

Career: Electronic Engineer or related.

Preferred Qualifications:

FDA, ISO 13485.

External and internal audit programs experience