Sr. SW Design Quality Assurance Engineer, Digital Products (Hybrid)
Insulet(1 month ago)
About this role
The Senior Software Design Quality Assurance Engineer ensures new products comply with the Insulet Quality System and applicable regulatory standards (FDA QSR, ISO 13485, ISO 14971). This role acts as the Quality representative for cloud-based product development and interfaces with cross-functional teams and external parties. The position communicates quality initiatives across the organization and supports product development by overseeing design control and software quality alignment.
Required Skills
- Design Control
- Software Quality
- Risk Management
- Regulatory Compliance
- IEC 62304
- Verification
- Validation
- Cybersecurity
- Requirements Analysis
- Test Planning
Qualifications
- ASQ
- CSQE
- BS in Engineering/Science/Computer Systems
- Master's Degree (preferred)
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