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.
About the Role
The role involves supervising the inspection of materials and finished products to ensure compliance with quality standards and technical requirements, while also managing non-conforming products and overseeing the quality management system.
Responsibilities
- Responsible for supervising the inspection of materials from external suppliers/contracted work to ensure that the production process complies with technical requirements and that finished products meet quality standards. Able to detect process abnormalities promptly.
- Supervise the final inspection of packaging boxes and the sampling of finished products to ensure compliance with standards.
- Oversee the management of non-conforming products, decide on the status of problematic items, and ensure proper segregation to prevent defective products from entering production.
- Record data and information from inspections, analyze, evaluate, and report. Monitor operations according to the quality management system in production to ensure system effectiveness.
- Inspect and supervise compliance with product and process quality standards, including analyzing the root causes of abnormalities and summarizing quality data.
- Check the daily work quality of inspection staff (e.g., inspection records, position adherence, working conditions) and use performance scores for monthly evaluation.
- Conduct internal departmental training and assign daily tasks to employees.
- Supervise the QC team's inspection reports to ensure timely completion and accuracy.
- Oversee the destruction/disposal of products according to requirements.
- Supervise proper and complete sample product management, ensuring traceability.
- Compile job-related statistical data and perform other duties assigned by supervisors.
Qualifications
- Diploma or Bachelor's degree or higher.
- 27 to 39 yrs old.
- At least 5 years of relevant work experience, including at least 2 years in management.
- Knowledge of laws and standards related to medical device quality control.
- Understand trends and developments in the medical device industry.
- Background in quality management and team management.
- ISO 13485 internal auditor certification (Medical Devices Quality Management Systems Requirements for Regulatory Purposes) is a plus.
- Skills in management, decision-making, communication, coordination, problem-solving, risk management, and execution.
- Able to recommend rejecting product launches or halting production when quality and safety risks are detected.
- Ensure effective operation of the quality management system and achieve the company's quality objectives through comprehensive control of personnel, processes, resources, and cross-departmental collaboration.
- Must guarantee achievement of company quality objectives under the quality management framework through standardized inspection, evaluation, management, and supervision.
- Work closely with production, R&D, and procurement teams to ensure smooth quality control processes.
- Experienced in communication with suppliers and regulatory authorities to ensure compliance with quality standards.
- Must be able to communicate in English.
Pay range and compensation package
Competitive salary based on experience and qualifications.
