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
Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.
Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.
Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.
Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
Strong in software design and development, software verification and validation activities
Review Design History Files and Technical Files for conformance to applicable requirements.
Participate when appropriate in audits
Demonstrates mastery of software development and testing methodologies
Independently develops test strategies for new, pre-concept features in development.
Provides guidance to associate and level 1 quality engineers.
Assesses the compliance of the software development methodology to the approved process.
Participate and provide input to training on department / division procedures and policies
Facilitates hazard analysis and SFMEA sessions. Updates the risk management file.
Acts as the subject matter expert on risk management for one or more products/platforms.
Ensures applicability to SOUP / OTS validations in the product development
Participates on CCB to decide upon CR implementation.
Applies quality system regulations, applicable standards and guidance to multiple projects
Develop templates and training based on the quality system regulations, applicable standards and guidance.
Independently reviews all SW deliverables to ensure compliance with development process and the standard.
Deliver presentations to the QA organization on status and issues of assigned projects.
Deliver training to departments outside of QA.
Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
Previous experience working in a cross-functional team environment.
Hands-on experience on Risk Management, Design Controls.
Provide Quality support to facilitate resolution of product complaints and/or safety issues
Provide support to the Regulatory Department in writing technical submissions.
6-8 years of experience.
Skills & Experience
Minitab, Minitab Quality Companion, Risk Management
Cyient is an Equal Opportunity Employer.

Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, ****** 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.