About the Company
TIANYI MEDICAL (THAILAND) CO.,LTD
The company 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. We are committed to delivering high-quality medical devices that meet the highest standards of safety and efficacy. Our mission is to innovate and improve healthcare through advanced technology and a dedicated workforce.
Responsibilities
- Responsible for sterilization research and process development during product design/development or change phases; complete sterilization process development, validation, revalidation, and supplemental activities as required, including ethylene oxide (EO) sterilization and radiation sterilization
- Responsible for evaluating changes and handling deviations related to radiation sterilization
- Responsible for assessing changes and sterilization deviations related to ethylene oxide sterilization
- Coordinate with and support regulatory authorities and customers in sterilization-related audits and communications
- Support and cooperate in implementing CAPA actions and maintaining/updating related quality system documentation
- Perform other ad hoc tasks assigned by management
Qualifications
- Bachelor's degree or higher
- Age between 2545 years
- At least 3 years of experience in sterilization-related work
- Familiar with sterilization standards such as ISO 11135, ISO 11137, TIR28, etc.
- Comprehensive knowledge and practical skills in sterilization; able to independently perform sterilization validation, prepare validation reports, and develop related SOP documents
- Familiar with the ISO 13485 quality management system, with some auditing experience
- Candidates holding relevant certifications or training in applicable standards will be given special consideration
- Physically fit with no health restrictions for pressure equipment work
- No criminal or major safety violation records
- Able to communicate in Thai and read basic English
- Pressure Vessel Operator License (R1) is an advantage
- GMP / sterilization / hazardous chemical training is a plus
Training Provided
Successful candidates will receive training in
- Pressure vessel operation
- EHS safety practices
- Medical device sterilization processes
- Process change updates
