Quality Management Assistant Manager

Key Responsibilities :

1. Develop, implement, monitor, and maintain the Quality Management System (QMS) to ensure compliance with applicable standards and regulations, including ISO 13485, ISO 17025, ISO 14971, GMP, Thai FDA, and U.S. FDA requirements
2. Promote quality awareness and ensure the effective implementation and enforcement of the company’s QMS and regulatory requirements to continuously improve processes, controls, and quality systems
3. Manage and assist in leading internal and external audits
4. Drive process owners to implement corrective and preventive actions to resolve identified issues
5. Control and update documents and quality records in accordance with QMS requirements
6. Monitor KPI results and report findings to management, including recommendations for improvement
7. Supervise both the Quality Control (QC) and Quality Assurance (QA) departments
8. Assist in organizing management review meetings
9. Manage FDA license renewals and updates in a timely manner

Qualifications:

• Bachelor's degree in Science, Engineering, or a related field
• At least 5 years of experience in quality system management or a related field
• Experience in the medical device industry is preferred
• Knowledge of GMP, ISO 13485, ISO 17025, Thai FDA, and US FDA requirements is an advantage
• Certified Internal Auditor is preferred
• Strong quality mindset, high motivation, logical thinking, problem-solving, and leadership skills
• Good command of English (both written and spoken)

Orthopeasia Co., Ltd.

32/6 Moo 11, T. Khlong Preng, Mueang Chachoengsao,
Chachoengsao 24000 Tel: 063-3631333

https://maps.app.goo.gl/B7x8T6gxBh64WWvS9

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