Technical Supervisor

About Tianyi Medical (Thailand) Co., Ltd.

Tianyi Medical (Thailand) Co., Ltd. is a subsidiary of Tianyi Medical Group, a leading manufacturer of Class III medical devices with over 30 years of industry experience. The company specializes in the development and production of high-quality medical consumables, including blood purification products, infusion therapy products, and other medical device components.

To support global business expansion, Tianyi Medical has established its manufacturing facility in Thailand at Amata City Industrial Estate, Rayong. The facility operates under international quality standards, including ISO 13485, and serves customers across China and international markets. We are committed to delivering innovative, reliable, and safe medical products while continuously improving our manufacturing capabilities and quality management systems.

Position Summary

The Technical Supervisor is responsible for managing and maintaining products transitioning from R&D to commercial production. This role focuses on process development, product maintenance, lean manufacturing, quality improvement, and production support to ensure stable and efficient manufacturing operations. The position also plays a key role in analyzing market complaints, optimizing production processes, and coordinating cross-functional teams to improve product quality and manufacturing performance.

Key Responsibilities

1. Product Transfer and Technical Management

• Convert R&D documentation, including BOMs, drawings, specifications, and process documents, into production-ready instructions for mass production.
• Maintain and control technical documentation for released products.
• Design and optimize manufacturing process flows and parameters.
• Plan, execute, and support process validation activities, including IQ, OQ, and PQ.
• Ensure production SOPs, work instructions, labels, and related process documents are complete, accurate, and up to date.

2. Lean Manufacturing and Process Improvement

• Continuously improve production processes to increase efficiency, reduce manufacturing costs, and enhance product quality and stability.
• Identify and implement process optimization opportunities to support operational excellence.

3. Quality Improvement and Complaint Investigation

• Investigate and analyze market complaints related to raw materials and manufacturing processes.
• Develop and implement corrective and preventive actions (CAPA) to eliminate root causes and prevent recurrence.
• Participate in product risk management activities and maintain process-related risk documentation.
• Drive continuous improvement initiatives to reduce product defects and improve process performance.

4. Production Support and Cross-Functional Coordination

• Review process documentation to ensure readiness and compliance with production requirements.
• Troubleshoot and resolve manufacturing and product quality issues.
• Collaborate closely with Production, Quality, and R&D teams to improve product design, manufacturability, efficiency, and cost performance.
• Participate in production meetings, follow up on action items, and ensure timely completion of assigned tasks.

5. Team Leadership

• Lead and supervise technical team members in daily operations.
• Support recruitment, training, coaching, performance evaluation, and skill development activities.
• Assign tasks and monitor team performance to ensure departmental objectives are achieved.

6. Additional Responsibilities

• Perform other duties and special assignments as directed by management.

Qualifications

Education

• Bachelor's Degree or above in Engineering, Biomedical Engineering, Materials Engineering, Mechanical Engineering, or related fields.

Experience

• Minimum 3 years of experience in Process Engineering, Manufacturing Engineering, or R&D within the Class III Medical Device industry.
• Hands-on experience with machining, extrusion, injection molding, welding, sterilization, or related manufacturing technologies.
• Strong understanding of medical-grade polymer materials and their processing methods.
• Familiarity with ISO 13485 requirements and applicable medical device regulations.

Technical Skills

• Strong knowledge of manufacturing processes, process validation, and product industrialization.
• Proficient in technical documentation management, process development, and continuous improvement methodologies.
• Competent in relevant engineering software and analysis tools.

Competencies

• Strong learning agility and problem-solving capability.
• Excellent analytical and critical-thinking skills.
• Innovative mindset with strong execution ability.
• Effective teamwork and communication skills.
• Ability to work professionally in English or Thai.

Authority

Advisory Authority

• Review and provide recommendations on technical documentation and process optimization.

Management Authority

• Control and approve process validation activities, drawings, BOMs, and process-related documentation.

Supervisory Authority

• Monitor compliance, accuracy, and effectiveness of manufacturing process documentation.

Coordination

Internal

• Collaborate effectively with R&D, Production, Quality Assurance, and other internal departments.

External

• Communicate and coordinate with suppliers, business partners, contractors, and other external stakeholders as required.

Working Schedule

• Working Hours: 08:00 AM – 05:00 PM
• Working Days:

Week A: Monday – Friday

Week B: Monday – Saturday

Alternate working schedule applies on a bi-weekly basis.

• Work Location: Amata City Industrial Estate, Rayong, Thailand

Salary:

• To be discussed based on qualifications and experience