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

Insmed Corporation

San Diego, CA, US
Base: $107,000.00 - $160,475.00; bonus/equity: eli...
Hybrid
Fda class ii and iii medical device experience
Iec 62304 software lifecycle compliance
Design history file document development
This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives

Job Summary

  • This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives.
  • The role ensures compliance with applicable standards including IEC 62304, ISO 14971, and FDA Guidance on Software Contained in a 510(k) Submission.
  • Compensation includes an annual base salary range of $107,000.00 - $160,475.00 along with comprehensive benefits like medical insurance and 401(k) matching.

Matching Summary

This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives.

Salary

Base: $107,000.00 - $160,475.00; Bonus/Equity: Eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) match, PTO

Skills & Requirements

Must-have

  • FDA Class II and III medical device experience
  • IEC 62304 software lifecycle compliance
  • Design History File document development
  • ISO 14971 risk management execution
  • Software validation and verification protocols
  • Cybersecurity Bill of Materials support

Nice-to-have

  • Cloud-based system development knowledge
  • Mobile application quality assurance
  • ASQ or CSQE certification preferred
  • Experience with COTS software validation
  • Strong analytical problem-solving skills
  • Ability to influence in fast-moving environment

Key Requirements

  • Minimum 8 years work experience in Software Quality Engineering
  • BS degree in computer science or equivalent field
  • Master's degree preferred
  • Working knowledge of FDA 21 CFR Part 820
  • Experience in regulated environment (FDA/ISO)

Work Rights

Not specified

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