Insulet is dedicated to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical technology
Job Summary
Insulet is dedicated to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical technology.
The role involves leading failure analysis, overseeing product testing, supporting laboratory equipment management, and participating in customer complaint handling and supplier audits.
Effective communication with global teams in both Chinese and English is essential to support quality system compliance and continuous improvement.
Matching Summary
Insulet is dedicated to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical technology.
Skills & Requirements
Must-have
ISO 13485 compliance
Device History Record review
Failure analysis methodologies
Corrective and Preventive Actions (CAPA)
Quality data analysis
Cross-functional communication in English and Chinese
Nice-to-have
Supplier audits and management
Medical device registration experience
International or cross-cultural work environment
Continuous improvement mindset
Quality training facilitation
Key Requirements
Bachelor’s degree in Engineering or related field
Minimum 2 years quality engineering experience
Solid knowledge of ISO 13485 and GMP
Proficient in quality tools like FMEA, SPC, 8D
Excellent English reading, writing, and speaking skills
Experience with CAPA management and risk assessment preferred
ISO 13485 internal auditor certification preferred