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# Senior Developer

- **Company:** HCL America, Inc.
- **Location:** United States
- **Experience:** Expert
- **Salary:** $59,000.0 - $99,000.0
- **Contract:** Permanent contract
- **Skills:** 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
- **Published:** October 11, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=84a8301a4163c490

## About the Role

* 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

## Description

Role: Software Quality Engineer