ISO Specialist

Resumen

is responsible for maintaining, monitoring, and continuously improving the Quality Management System (QMS), ensuring compliance with applicable ISO standards, internal policies, customer requirements, and manufacturing procedures.

Responsabilidades

Main Responsibilities:

• Maintain, monitor, and continuously improve the Quality Management System (QMS) in accordance with ISO 9001 requirements.
• Ensure compliance with internal quality policies, procedures, work instructions, standards, and customer requirements.
• Plan, coordinate, and conduct internal quality audits across manufacturing processes and support functions.
• Support external, certification, surveillance, recertification, and customer audits.
• Identify nonconformities, process deviations, and potential compliance risks.
• Coordinate and follow up on corrective and preventive actions to ensure timely and effective closure.
• Facilitate root cause analysis using methodologies such as 5 Whys, Fishbone Diagram, 8D, and Pareto Analysis.
• Track audit findings and ensure corrective action plans are implemented and verified for effectiveness.
• Manage the document control system, including procedures, work instructions, forms, policies, records, and related QMS documentation.
• Ensure current and approved documentation is available at the appropriate points of use.
• Coordinate document revisions and changes related to manufacturing and quality processes.
• Monitor and report Quality Management System KPIs and performance indicators.
• Prepare QMS performance information and supporting documentation for Management Review meetings.
• Partner with Production, Manufacturing Engineering, Quality, Maintenance, Materials, Supply Chain, and other departments to ensure ISO compliance.
• Provide training and guidance to employees regarding ISO requirements, quality procedures, document control, and QMS expectations.
• Promote and participate in continuous improvement initiatives to reduce risks, process deviations, and recurring nonconformities.
• Support risk assessments related to manufacturing processes, operational changes, and quality systems.
• Maintain objective evidence and quality records required to demonstrate compliance during audits.
• Monitor action plans resulting from audits, quality issues, process deviations, and compliance findings.
• Support process standardization across manufacturing operations.
• Identify opportunities to improve the effectiveness and efficiency of the Quality Management System.

Education

Bachelor's degree in:

• Industrial Engineering
• Manufacturing Engineering
• Quality Engineering
• Mechanical Engineering
• Electromechanical Engineering
• Industrial Management
• Or a related engineering or technical field.

Experience

• Minimum 2-3 years of experience in Quality Management Systems within a manufacturing environment.
• Hands-on experience with ISO 9001 requirements and implementation.
• Experience conducting internal audits and supporting external audits.
• Experience managing corrective actions and nonconformities.
• Experience with document control and QMS documentation.
• Experience working with cross-functional manufacturing teams.
• Experience in the metal-mechanical, automotive, refrigeration, electronics, or high-volume manufacturing industry is preferred.