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.

Preferred Qualifications: FDA, ISO 13485.