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Product Quality Engineer- Medical Devices

4.00 to 9.00 Years   Hyderabad   30 May, 2022
Cyient Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    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 DescriptionA 4-10 years of experience in product QA lifecycle , Sustenance product design LCMin medical device industryCompetency :Quality Management ISO 1485- Risk Management- Design Controls and change Management- Quality Assurance - Quality Engineering- Design Transfer / Supplier quality engineeringHands on experience in Medical Device design and development projects per QualityManagement Systems (ISO 13485), Design controls (US FDA 21CFR 820. Part 30), and RiskManagement (per ISO 14971).Coordinating with manufacturing team to develop the Process Validation testing (IQ,OQ, PQ).Application of ISO 14971, Medical Device-Application of Risk Management for thevarious product families belonging to Hypo Disposable Medical Devices.Updated Risk Management documents for the stand-alone products.Interaction with Cross function teams regularly over the globe.Skills & ExperienceISO 13485:2003- Quality in Medical Devices, Medical Technology & Healthcare, Quality Assurance, Quality Control, Quality Management systemCyient 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 :
automationproduct qualityagilesupplier quality engineeringvalidation

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