Senior Sw Design Quality Assurance Engineer, Cloud Sw (hybrid)

Insulet

Multiple Locations, , US
Base: $85,125.00 - $127,687.50; bonus/equity: not ...
Hybrid
Software quality engineering in fda environment
Quality system regulation compliance
Cloud-based product development
The Senior SW Design Quality Assurance Engineer ensures new products conform to regulatory standards including ISO 13485 and ISO14971 and supports continuous improvement initiatives

Job Summary

  • The Senior SW Design Quality Assurance Engineer ensures new products conform to regulatory standards including ISO 13485 and ISO14971 and supports continuous improvement initiatives.
  • This role collaborates cross-functionally with departments such as R&D, Product Security, DevOps, and Regulatory Affairs to maintain quality and compliance for cloud-based medical device software.
  • The position offers a hybrid working arrangement requiring onsite presence at least three days per week and supports career growth through project direction and mentoring.

Matching Summary

The Senior SW Design Quality Assurance Engineer ensures new products conform to regulatory standards including ISO 13485 and ISO14971 and supports continuous improvement initiatives.

Salary

Base: $85,125.00 - $127,687.50; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Software Quality Engineering in FDA environment
  • Quality System Regulation compliance
  • Cloud-based product development
  • Risk Management Plan execution
  • Design control documentation review
  • QMS PLM tools utilization

Nice-to-have

  • ASQ or CSQE certification
  • Experience with AWS
  • Mentoring and coaching skills
  • Strong analytical and problem-solving
  • Ability to manage multiple responsibilities
  • Excellent communication skills

Key Requirements

  • Minimum 5 years software quality engineering experience
  • Degree in engineering/scientific/computer systems or equivalent
  • Experience with medical device software development
  • Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62304
  • Experience with software development lifecycles
  • Experience in quality documentation creation and maintenance

Work Rights

Not specified

Tailored Resume

Cover Letter