Quality Management Representative

2 weeks ago

Bangkok, Bangkok, Thailand FUJIFILM (Thailand) Ltd. Full time ฿1,200,000 - ฿2,400,000 per year

Position Overview:

The Quality Management Representative (QMR) is responsible for overseeing and managing the company's quality management systems (QMS) to ensure compliance with regulatory requirements and international standards such as document control and incoming ISO, relevant Thai FDA license and practice. The QMR leads internal and external audits, coordinates corrective and preventive actions, manages documentation control, and facilitates management reviews. This role also supports the company in submissions for new ISO certifications and relevant practice and license of THAI FDA and acts as the key liaison with certification bodies and regulatory agencies.

Key Responsibilities:

  • Develop, maintain, and coordinate the internal audit schedule, supporting both internal teams and external customers during audits.

  • Submit application for new ISO certifications and other mandatory practice including ISO 9001:2026, ISO 13485, Good Importing Practices, Good Distribution Practice and relevant Thai FDA license and permit and manage application and documentation necessary for new ISO certifications, ensuring timely and accurate compliance with certifying authorities.

  • Manage regulatory and quality system audits for those relevant certificates, practices and licenses.

  • Lead the Corrective and Preventive Actions (CAPA) process by coordinating responses to audit findings, monitoring action status, and ensuring effective resolution.

  • Act as the leader of the review board to ensure CAPA effectiveness and compliance.

  • Maintain and control quality and environmental management documents within the Document Control System (DCS).

  • Manage any relevant submission and document preparation for the change of relevant procedure obligated to notification to the certification bodies (Certify Body) or other authority.

  • Train, mentor, and support team members on ISO 9001, ISO 13485, Good Importing Practices, Good Distribution Practice and relevant Thai FDA license and permit, requirements, and CAPA procedures.

  • Oversee system, process, and product audit planning and execution in alignment with internal policies and certification requirements.

  • Liaise and coordinate with certification bodies (Certify Body) for audit scheduling, compliance verification, and certification maintenance, change of relevant procedure.

  • Ensure compliance with applicable legal and regulatory requirements and maintain updated registers related to quality, environment, and safety standards.

  • Review and communicate Quality Management Systems (QMS) and Environmental Management System (EMS) policies, objectives, and requirements to all relevant employees and stakeholders.

  • Prepare and present audit results, KPI reports, and summaries to management, supporting quarterly Management Review meetings.

  • Facilitate quality patrols, monthly reporting, and quality-related events or exhibitions.

  • Monitor daily quality operations, KPI achievements, and support continuous improvement initiatives within the organization.

Qualifications and Skills:

  • Proven experience in quality management roles, particularly related to ISO 9001, ISO 13485,and regulatory audits.

  • Strong knowledge of internal and external audit processes, CAPA management, and regulatory compliance.

  • Excellent communication and leadership skills to train team members and coordinate cross-functional teams.

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