Quality Assurance Engineer

Insmed

Iso 13485 and gmp regulations knowledge
Device history records (dhr) review
Product failure analysis (fa) leadership
The company aims to enable customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical technology

Job Summary

  • The company aims to enable customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical technology.
  • Responsibilities include leading product failure analysis, reviewing Device History Records, and overseeing batch product functional testing.
  • The role requires effective communication with global stakeholders in both Chinese and English while ensuring compliance with ISO 13485.

Matching Summary

The company aims to enable customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical technology.

Skills & Requirements

Must-have

  • ISO 13485 and GMP regulations knowledge
  • Device History Records (DHR) review
  • Product Failure Analysis (FA) leadership
  • CAPA implementation and management
  • Advanced data analysis skills

Nice-to-have

  • Continuous improvement mindset
  • Cross-cultural work environment experience
  • Proactive quality project drive
  • Supplier audit participation
  • International team communication

Key Requirements

  • Bachelor's degree in Engineering or related field
  • Minimum 2 years of medical device quality experience
  • Mandatory advanced English reading, writing, and speaking skills

Work Rights

Not specified

Tailored Resume

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