Job Summary
- 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.
Key Responsibilities
Role: Software Quality Engineer
- 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.
Skill 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.
Other Requirements
Bachelor’s degree in Computer science, Software Engineering or related field