About Tianyi Medical (Thailand)
Tianyi Medical (Thailand) is a subsidiary of Tianyi Medical, a leading manufacturer of Class III medical consumables with over 30 years of experience in the medical device industry. Headquartered in China, Tianyi Medical specializes in the research, development, manufacturing, and distribution of high-quality medical devices and consumables for global healthcare markets.
The company operates under an ISO 13485 certified Quality Management System, and its products comply with international regulatory requirements, including NMPA, CE, FDA, and other applicable certifications. Tianyi Medical serves customers across Asia, Europe, North America, and South America.
Our product portfolio includes blood purification consumables, infusion and nutrition devices, rehabilitation products, and other medical consumables designed to support healthcare professionals and improve patient outcomes worldwide.
As our business continues to grow, we are looking for talented and passionate professionals to join our team and contribute to the development of innovative, high-quality medical solutions for the global healthcare industry.
Job Descripti
- onResponsible for sterilization process research and development activities, including process design, development, changes, validation, revalidation, and other related sterilization activities for Ethylene Oxide (EO) and Radiation Sterilization processe
- s.Responsible for evaluating change controls and deviations related to EO sterilization processe
- s.Responsible for evaluating change controls and deviations related to radiation sterilization processe
- s.Provide technical support and collaborate with regulatory authorities and customers during audits, inspections, and sterilization-related communication
- s.Support the maintenance and continuous improvement of CAPA activities and related quality system documentatio
- n.Manage process validation projects, including planning, execution, monitoring, and reporting of validation activitie
- s.Oversee validation processes to ensure all activities are completed according to approved plans and applicable validation standard
- s.Coordinate with cross-functional teams, including Production, Research & Development (R&D), Quality Control (QC), and Quality Assurance (QA), to ensure the effectiveness and compliance of validation activitie
- s.Coordinate with external parties, such as suppliers and relevant organizations, to ensure validation requirements and conditions are me
- t.Provide technical guidance and recommendations to project teams and senior management regarding process improvement and validation strategie
- s.Perform other duties as assigned by the superviso
r.
Qualificati
- ons25
- -40Minimum 3 years of experience in sterilization processes or sterilization validati
- on.Familiar with sterilization standards and guidelines, including ISO 11135, ISO 11137, and TIR
- 28.Possess comprehensive knowledge of sterilization principles and techniques, with the ability to independently perform sterilization validation, prepare validation protocols, reports, SOPs, and related documentati
- on.Familiar with ISO 13485 Quality Management System and experienced in supporting internal and external audi
- ts.Strong communication and coordination skil
- ls.Strong problem-solving skil
- ls.Good learning agility and adaptabili
- ty.Risk management capabili
- ty.Strong analytical skil
- ls.Strong execution and project management skil
- ls.Ability to provide recommendations to project teams and senior management on process improvement and validation strategi
es.
