Production Manager

Tianyi Medical is a leading manufacturer of Class III medical devices and medical consumables with more than 30 years of experience in the medical device industry.

Tianyi Medical (Thailand) has established its manufacturing facility in Rayong, Thailand to support its international business expansion. The company focuses on the R&D, manufacturing, and global distribution of medical consumables and devices, including blood purification products, infusion devices, nutrition systems, rehabilitation equipment, and medical hygiene products.

The company operates under international quality and regulatory requirements, including ISO 13485, with products serving markets in China and overseas markets across Asia, Europe, America, and South America.

About the Role

We are looking for an experienced Regulatory Affairs Specialist to join our team and support regulatory activities for medical devices in Thailand and international markets.

This role will focus on Thailand FDA registration, ASEAN regulatory submissions, and coordination of US FDA activities, ensuring regulatory compliance throughout the product lifecycle.

Job Responsibility

1. Production Planning

1.1 Prepare the department’s annual, quarterly, and monthly production plans, and allocate tasks reasonably based on market demand and orders.

1.2 Monitor production progress, adjust production plans in a timely manner, and respond flexibly to market changes and emergencies to ensure continuous and stable production.

2. Quality Management

2.1 Implement the quality system, standardize production processes, including records and reports, to ensure production data is accurate and complete.

2.2 Supervise quality control stages, strictly inspect raw materials, production processes, and finished products to ensure products meet standards

2.3 Analyze the causes of production non-conformities, take corrective and preventive measures, assist in non-conformance review, close non-conformance items, and continuously improve quality.

3. Team Management

3.1 Coordinate recruitment, training, and performance management to enhance team capabilities, and select and develop backup talent.

3.2 Organize production scheduling meetings, clarify production tasks and timelines, coordinate work across departments, ensure smooth task handover, and foster an efficient and collaborative working environment.

4. Cost Control

4.1 Monitor production costs, optimize resource allocation, implement cost-reduction measures, and improve economic efficiency.

5. Safety Management

5.1 Enforce safety regulations, organize safety training, and ensure safe production.

6. On-site Management

6.1 Implement 5S management, maintain a clean and organized production area, optimize site layout, and enhance efficiency and employee morale.

7. Cross-department Coordination and Communication

7.1 Assist the R&D department in trial production of new products, provide feedback and suggestions, and support smooth mass production.

7.2 Cooperate with the technical department to improve processes, provide necessary support, and enhance production efficiency and quality.

7.3 Communicate and collaborate closely with Purchasing, Warehouse, Quality, Sales, and other departments.

8.General Department Management Responsibilities

8.1 Organize the formulation of internal management systems and process frameworks for the department, and ensure continuous updating and optimization

8.2 Organize the preparation of departmental work plans and budgets.

8.3 Manage the full employee lifecycle, including selection, training, utilization, retention, and separation.

8.4 Timely summarize work experience and lessons learned, document them for knowledge transfer.

8.5 Coordinate and prepare departmental documents and on-site checks during internal and external audits.

8.6 Strengthen professional guidance and supervision of subsidiaries/workshops, promptly identify issues, and ensure corrective actions are implemented.

Job Qualifications

1. Associate degree or above, major in Production Management or related fields.

2. Aged 30-45 years old

3. Over 8 years of experience in production management, with at least 3 years in the same position.

4. Familiar with production processes, proficient in office software and production management tools, and knowledgeable about relevant laws, regulations, and quality system documents in the industry.

5. Training certificates related to production management are preferred.

6. Strong strategic planning, team management, decision-making, communication and coordination, planning, and risk management skills.

7. Proficient in English