Sr Quality Assurance Engineer

Insulet

Cn, China
Quality system regulation compliance
Iso 13485 and iso 14971 expertise
Risk management plan execution
Insulet is dedicated to enabling customers to enjoy simplicity, freedom and healthier lives through innovative wearable technology

Job Summary

  • Insulet is dedicated to enabling customers to enjoy simplicity, freedom and healthier lives through innovative wearable technology.
  • The Senior Quality Engineer ensures product compliance with quality systems and regulatory standards while collaborating with cross-functional teams.
  • This role involves supporting new product introduction, risk management, manufacturing process development, and providing project guidance.

Matching Summary

Insulet is dedicated to enabling customers to enjoy simplicity, freedom and healthier lives through innovative wearable technology.

Skills & Requirements

Must-have

  • Quality System Regulation compliance
  • ISO 13485 and ISO 14971 expertise
  • Risk Management Plan execution
  • Design control documentation review
  • Manufacturing process qualification
  • Statistical process control methods

Nice-to-have

  • Effective verbal and written communication
  • Cross-functional team collaboration
  • Problem solving and root cause analysis
  • Coaching and mentoring skills
  • Technical report writing

Key Requirements

  • BS degree in engineering or scientific discipline
  • 5-7 years experience in FDA regulated environment
  • Experience with QSR Part 820
  • Experience with ETO sterilization methods preferred
  • Master’s degree preferred

Work Rights

Not specified

Tailored Resume

Cover Letter