Staff Sw Quality Assurance Engineer (hybrid-san Diego, Ca)

Insulet

San Diego, CA, US
Base: $107,000.00 - $160,475.00; bonus/equity: may...
Hybrid
Software development life cycle compliance
Design control for fda class ii and iii devices
Cybersecurity risk management
This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and automated data processing systems used as part of the quality system

Job Summary

  • This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and automated data processing systems used as part of the quality system.
  • The role supports compliance with FDA regulations and industry standards such as IEC 62304, ISO 13485, and ISO 14971, including cybersecurity development processes and risk management.
  • Insulet offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and additional employee wellness programs.

Matching Summary

This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and automated data processing systems used as part of the quality system.

Salary

Base: $107,000.00 - $160,475.00; Bonus/Equity: May be eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) with match, PTO, wellness programs

Skills & Requirements

Must-have

  • Software Development Life Cycle compliance
  • Design Control for FDA Class II and III devices
  • Cybersecurity risk management
  • IEC 62304 and FDA software guidance compliance
  • Software quality assurance processes
  • Risk Management per ISO 14971

Nice-to-have

  • Effective verbal and written communication
  • Ability to manage multiple responsibilities
  • Experience with cloud-based medical software
  • Collaboration across departments
  • Continuous Improvement initiatives
  • Training delivery for software teams

Key Requirements

  • BS degree in computer science or equivalent
  • Minimum 8 years software quality engineering experience
  • Experience in FDA, ISO, or regulated environment
  • Knowledge of FDA 21 CFR Part 820 and ISO 13485
  • Familiarity with IEC 62304, ISO 14971, IEC 62366, IEC 60601
  • Experience with Design Control Systems
  • ASQ or CSQE certification beneficial

Work Rights

Not specified

Tailored Resume

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