ISO Manager

Duties and Responsibilities

• Plan, control, and manage the company's quality systems in accordance with ISO 9001, IATF 16949, ISO 13485, ISO 14001, and ISO 23907-1 standards.
• Oversee the preparation, control, review, and improvement of quality system documents such as Manual, Procedure, WI, Form, and Record.
• Plan and manage Internal Audit, including serving as the main coordinator for External Audit / Certification Audit / Customer Audit.
• Monitor and analyze Non-Conformity (NC) and control the implementation of Corrective Action / CAPA.
• Analyze root causes of problems using tools such as 5 Why, Fishbone Diagram, and 8D.
• Prepare and conduct Management Review meetings.
• Monitor and analyze KPI, Quality Trend, Audit Result, Customer Complaint, and system effectiveness.
• Oversee the IATF 16949 system and customer requirements, including Automotive Core Tools such as APQP, PPAP, FMEA, SPC, and MSA.
• Oversee the ISO 13485 system and requirements related to Medical Device products.
• Oversee requirements and compliance with ISO 23907-1 standards for related products.
• Provide consultation and training to employees regarding ISO / IATF requirements and quality systems.
• Coordinate with internal departments, customers, Auditors, and Certification Bodies.
• Report quality system performance, problems, risks, and improvement guidelines to management.
• Drive Continuous Improvement activities and continuously develop system efficiency.
• Perform other duties as assigned.

Qualifications: Female, aged 25-35 years and above. Bachelor's degree or higher in Engineering, Science, Industrial Management, or related fields. At least 5 years of experience in ISO / Quality Management System. At least 2–3 years of experience at Supervisor, Assistant Manager, or Manager level. Experience in a manufacturing industrial plant. Good knowledge and experience in ISO 9001 and IATF 16949. Experience in ISO 13485 / Medical Device will be given special consideration. Knowledge of ISO 14001. Knowledge of Automotive Core Tools, namely APQP, PPAP, FMEA, SPC, and MSA. Experience in Internal Audit, External Audit, and Customer Audit. Ability to analyze Root Cause and prepare Corrective Action / CAPA. Leadership skills, with the ability to manage a team and coordinate well with various departments. Analytical skills, problem-solving skills, and the ability to present information to management. Proficiency in Microsoft Office. Ability to communicate in English, read standards, and communicate with Auditors or customers.