Quality Manager

About the Company

TIANYI MEDICAL (THAILAND) CO.,LTD is a well-established manufacturer of Class-III medical consumables with over 30 years of experience. It is certified with ISO 13485 QMS, and its products hold China NMPA registration, with some also certified by 3C (China), CE (EU), and FDA (US). The product range includes blood purification consumables, nutrition devices, I.V. catheters and infusion devices, physical therapy and rehabilitation devices, medical polymers, hygiene materials, and ward care apparatuses. With advanced equipment, strong environmental protection measures, and a robust quality control system covering all stages from raw material procurement to product delivery, the company ensures high product quality. Its products are sold across major Chinese cities and internationally in Asia, Europe, America, and South America, establishing a strong brand presence for TYH in both domestic and global markets.

Job Responsibilities

1. Quality System Assurance

Develop and oversee the Quality Management System (QMS) according to policies and objectives. Manage QMS documentation, set and monitor quality goals, conduct internal audits, organize management reviews, handle external audits, control changes in the QMS, and drive continuous improvement to enhance product quality and process efficiency.

2. Quality Engineering

Develop and supervise control plans, participate in new product development, define and implement quality standards, conduct process validation, identify production abnormalities, organize corrective and preventive actions, and manage supplier quality performance to ensure compliance with requirements.

3. Quality Control

Oversee incoming, in-process, and final inspections, ensure accurate and reliable records, review non-conforming products and corrective measures, approve and supervise scrap handling, manage sample retention, and verify inspection personnel qualifications.

4. Laboratory Management

Establish laboratory management standards and supervise implementation to ensure safe operations.

5. Monitoring and Measuring Equipment Management

Set equipment management standards and ensure instruments and equipment are used within calibration validity periods.

6. General Departmental Management

Develop and optimize internal departmental systems and processes, prepare work plans and budgets, manage talent including recruitment, training, utilization, retention, and exit, document lessons learned for knowledge transfer, provide professional guidance, and supervise company product quality to ensure timely corrective actions.

Qualifications

1.Bachelor's degree or above

2.35 - 50 years old.

3.Over 10 years of experience in quality management

4.Knowledge: Quality management knowledge, industry knowledge, management knowledge, etc.

5.Skills: Proficient in quality management tools and methods, such as ISO 9001, Six Sigma; software skills, including quality management software; communication skills, with the ability to handle scenarios such as business negotiations.

6.ISO 13485 Internal Auditor

7.Six Sigma Certification

8.Strategic planning ability

9.Team management ability

10.Decision-making ability

11.Leadership

12.Communication and coordination skills

13.Problem-solving ability

14.Risk management ability

15.Able to communicate in English only.