Senior Developer
HCL America, Inc.
United States
23 days ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
2 years minimum
Compensation
$59,000.0 - $99,000.0
Working hours
Regular working hours
Job source
Tech stack
Computer-Aided Design
Software Quality
Cyber Security
Software Design Documents
Failure Mode Effects Analysis
Medical Software
Software Product Management
Systems Development Life Cycle
Software Engineering
Software Quality Assurance (SQA)
Information Technology
Job description
Role: Software Quality Engineer
Requirements
- 2-3years of product software experience in Medical devices domain
- Experience in drafting Software based QMS procedures & work instructions (including third party softwares).
- Strong knowledge of SDLC, software quality, and quality management systems.
- Experience working in Agile/Scrum environments and knowledge of SDLC methodologies
- Lead quality engineering activities, including Software risk assessments (RMF, FMEA, Cybersecurity) and Quality plan execution.
- Manage CAPA investigations, root cause analysis, corrective actions, and effectiveness monitoring.
- Review and approve requirements, design documents, test protocols, test results, and change requests., * 2-3years of product software experience in Medical devices domain
- Experience in drafting Software based QMS procedures & work instructions (including third party softwares).
- Strong knowledge of SDLC, software quality, and quality management systems.
- Experience working in Agile/Scrum environments and knowledge of SDLC methodologies
- Lead quality engineering activities, including Software risk assessments (RMF, FMEA, Cybersecurity) and Quality plan execution.
- Manage CAPA investigations, root cause analysis, corrective actions, and effectiveness monitoring.
- Review and approve requirements, design documents, test protocols, test results, and change requests.
Must Have Skill
Medical Device - Medical Software Quality Management,Medical Device - Software Quality Assurance,Regulatory Quality System, Bachelor’s degree in Computer science, Software Engineering or related field
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