About the Company
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.
About the Role
Responsible for performing sterilization validation and re-validation in accordance with standards and regulations to ensure the sterilization process remains stable and reliable.
Responsibilities
- Process Development & Validation: Design and develop sterilization processes during the product design or change stages. Execute sterilization process development, confirmation, re-validation, and supplements for both Ethylene Oxide (EO) and Irradiation sterilization.
- Anomaly Assessment: Responsible for evaluating changes and abnormalities related to Ethylene Oxide and Irradiation sterilization processes.
- Audit Support: Coordinate and support regulatory agencies, customers, and other stakeholders regarding sterilization-related audits and communications.
- Quality System Maintenance: Support Corrective and Preventive Actions (CAPA) and maintain/update relevant quality management system documents.
- Other Tasks: Perform temporary tasks as assigned by the supervisor.
Qualifications
- Education: Bachelor's Degree
- Age: 2545 years old
- Work Experience: Minimum of 3 years of experience in sterilization validation.
Required Skills
- Familiar with sterilization standards such as ISO 11135, ISO 11137, and TIR 28.
- Comprehensive mastery of sterilization knowledge; able to independently complete sterilization confirmations, output protocols/reports, and related SOP documents.
- Familiar with ISO 13485 Quality Management Systems with audit experience.
Preferred Skills
- Training/Certificates: Candidates with relevant standard training certificates are preferred.
- Competencies: Coordination, Problem-solving, Learning agility, Risk management, Analytical skills, and Strong execution.
