Job Description
Educational Qualification: Bachelor's degree in Computer science, Software Engineering or related field
Job Description: - 5+ years 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.
Numbers & Facts
| Location | Sylmar, CA |
| Industry | Other/Not Classified |
| Company Size | 100 to 499 employees |
Skills
Agile Programming Methodologiesunmatched
Change Requests/Ordersunmatched
Computer Scienceunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Design Documentunmatched
Failure Mode and Effects Analysis (FMEA)unmatched
Internet Securityunmatched
Medical Equipmentunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Risk Analysisunmatched
Root Cause Analysisunmatched
Scrum Project Management and Software Developmentunmatched
Software Development Lifecycle (SDLC)unmatched
Software Engineeringunmatched
Test Designunmatched
Testingunmatched
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