Sr. SW DQA Engineer - Embedded SW (Hybrid - Acton, MA)
US - Massachusetts (Acton - Office), United States
USD 87K-130K Senior-level Full Time
Tasks
- Advise teams on distribution market regulations
- Apply data driven problem solving for quality issues
- Conduct cybersecurity risk management
- Ensure compliance with design controls and quality system
- Ensure embedded software quality compliance throughout development
- Execute software development life cycle compliance
- Maintain configuration management and design transfer
- Maintain verification plans test protocols and test reports
- Manage requirements tracing and defect tracking
- Oversee design history file deliverables
- Perform design and code reviews
- Provide guidance on requirements and design documentation
- Review approve design control documentation
- Support manufacturing process development and qualification
- Support risk management activities
Perks/Benefits
- 401k match
- Employee wellness programs
- Hybrid working arrangement
- Medical, dental, and vision insurance
- Paid time off
Skills/Tech-stack
21 CFR part 820 | CFR Part 820 | Code Reviews | Configuration Management | Control Systems | Cybersecurity Risk Management | Cybersecurity risk | Defect Tracking | Design Controls | Design History File | Design history | Design reviews | Development Life Cycle | Embedded Software | FDA 21 CFR | FDA 21 CFR Part 820 | FMEAs | IEC 60601 | IEC 62304 | IEC 62366 | ISO 13485 | ISO 14971 | Operating Systems | Part 820 | RTOS | Real Time | Real-time operating systems | Requirements Management | Risk Management | Signal Processing | Software Development Life Cycle | Software development | Test Protocol | Test report | Traceability matrix | Verification Plan
Education
Regions
Countries
States
Cities
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