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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | IT - Software |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Cyient is a global engineering and technology solutions company. As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.Job DescriptionSkills Matrix: DHF Remediation, Risk management, Change control Management, NC/CAPA, Design verification, ISO 13485, ISO 14971No. of years of experience: 3-8 yearsCarry out DHF remediation activities as per approved remediation plan.EU-MDR implementation experienceFDA (510K) submission experience.Perform risk management and risk analysis activities. Develop protocols and procedures. Carryout Root cause analysis and work on NC/CAPA resolution. Technical writing reports and technical justification. Develop understanding in functional / system testing of medical devices.Skills & Experience21 CFR 820, Change Control Processes, Design Verification, FDA Quality System Regulation, ISO 13485 Medical Devices, ISO 14971 Risk Management, Medical Device Regulations, Medical Devices Design, Risk Analysis, Risk Management, Risk Management AssessmentCyient is an Equal Opportunity Employer.Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.,
Keyskills :
root cause analysisiso 13485medical devicesquality systemchange controlroot causerisk managementrisk analysisiso 14971technical writingsystem testing