Staff SW Quality Assurance Engineer (Hybrid)
Insulet(3 months ago)
About this role
The Staff Software Design Quality Assurance Engineer leads quality assurance and quality engineering efforts across the software development lifecycle for medical device products and automated quality-system tools. The role ensures software development processes meet applicable regulatory standards and guidance (including cybersecurity requirements) and partners with internal teams and external stakeholders to support product development and post-launch support. This position supports design control documentation and compliance activities for FDA Class II/III devices, mobile and cloud-based systems.
Required Skills
- Quality Assurance
- Quality Engineering
- Design Controls
- IEC 62304
- Risk Management
- Software Validation
- Cybersecurity
- Requirements Analysis
- Verification
- Validation
+3 more
Qualifications
- BS in Computer Science or Computer Engineering
- Master's Preferred
- ASQ
- CSQE
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