Quality Management Representative (QMR)

Quality Management System (QMS):

1. Develop, implement, monitor, and maintain the Quality Management System to meet applicable standards (e.g., ISO 13485, ISO 17025, ISO 14971, GMP, Thai FDA, and US FDA regulations).

2. Promote quality awareness and ensure the implementation and enforcement of the company’s QMS and regulatory requirements to improve current processes, controls, and quality systems.

3. Manage and lead internal and external audits.

4. Drive process owners to take corrective and preventive actions to resolve issues.

5. Control and update documents and quality records in accordance with system requirements.

6. Monitor KPI results and report to management with recommendations for improvement.

7. Supervise both QC and QA department.

8. Organize 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: 063-363-1333
www.orthope.com

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