Ing de Aseguranza de Calidad I

Avanos Medical; Tijuana; On-site; MXN 300,000 - 480,000; Full time

Job summary

Avanos Medical in Baja California seeks a Quality professional to develop quality functions and improve the quality system, resolving production and product issues that affect quality, promoting training and regulatory compliance, and supervising quality personnel as required.

You will lead audits, validate new processes, analyze defects, and drive continuous improvement with multidisciplinary teams, including transferring processes to the Tijuana plant and supporting customer complaints.

Qualifications

• English: Advanced level.
• Experience: More than 2 years of experience in the quality department.
• Career: Electronic Engineer or related.
• FDA, ISO 13485 compliance experience.

Responsibilities

• Develop inspection procedures and test methods to support in-process and quality inspectors in manufacturing areas and labs.
• Coordinate and train on new or modified inspection procedures.
• Analyze sampling plans using AQL, RQL, and Cpk for attribute and variable data.
• Carry out audits of production processes to verify compliance with procedures and control plans.
• Participate in Internal and External Audit programs.
• Support validations of new processes, test methods, equipment, or products (IQ, OQ, PQ, TMV).
• Analyze defects and quality issues to determine trends and propose corrective actions.
• Lead multidisciplinary teams to implement improvements in manufacturing processes.
• Supervise inspection resources (quality inspectors and auditors).
• Be part of teams to transfer products/processes to the Tijuana plant.
• Investigate customer complaints and establish improvements.

Skills

Advanced English

Education

Electronic Engineer or related

Job description

Job Position Purpose

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.

Job Position Accountabilities

• Development inspection procedures and test methods to provide support to in-process and quality inspectors in manufacturing areas and functional testing labs.
• Coordinate and give training on new or modified inspection procedures.
• Analysis and development of sampling plans to be used for inspection (using corresponding AQL, RQL, Cpk for attribute and variable data).
• 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.
• Participate in the Internal and External Audit program.
• Support in the execution of validations of new processes, test methods, equipment, or products (IQ, OQ, PQ, TMV).
• Analyze defects and quality issues in production to determine trends and recommend corrective actions and/or changes of inspection criteria, conduct statistical analysis, and propose solutions based on the results.
• Participate in multidisciplinary teams and projects for continuous improvement.
• Supervision of inspection resources (quality inspectors and auditors) as required.
• Lead multidisciplinary teams to implement improvements in manufacturing processes as required.
• Be part of multidisciplinary teams to introduce and/or transfer products or processes to the Tijuana plant.
• Support in the investigation of customer complaints and establish improvements as required.
• Monitor quality metrics and act as required.
• Manage the non-conforming material system (material dispositions, support in containment actions, investigation, and corrective actions; follow up on corrective actions, promote compliance with established activity dates).

Qualifications / Education / Experience / Skill Required

• English: Advanced level.
• Experience: More than 2 years of experience in the quality department.
• Career: Electronic Engineer or related.
• FDA, ISO 13485.