Analyst – Business Process 101 views

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 Description Experience in planning & executing Quality Assurance Activities from Kickoff to Release Experience in implementing Quality Management System across Projects using ISO 9001:2015 and ISO 13485 Familiar with medical industry standards ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR part 820, EUMDR Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and EU MDR. Independently reviews all deliverables to ensure compliance with development process and the applicable standards. Participate on cross-functional teams to develop product risk management file Review Design History Files and Technical Files for conformance Deliver Process Related trainings to Project Teams on QMS, Quality Standards Good understanding of Project Management Life Cycle Activities – Project Initiation, Project Planning, Monitoring & Control and Project Closure Good experience in internal quality audits – Process compliance Audit, Internal quality Audit, Configuration Management Audit Report, Track and Escalate Process/Product Non Conformances to relevant stakeholders Experience in conducting Root Cause Analysis for problems, issues and defects Delivers presentations to the QA organization on status and issues of assigned projects. Skills & Experience Internal Audits, ISO 13485 Medical Devices, Software Quality Assurance (SQA) Cyient 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.