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Division Senior Manager

10.00 to 12.00 Years   Hyderabad   15 Feb, 2022
Cyient Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    A 10 years of experience in product QA lifecycle , Sustenance product design LCM in 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 & ExperienceCustomer Quality, Design Quality, ISO 13485:2003- Quality in Medical Devices, Management of Product & Facility quality systems, Medical Device Product Development Experience, Medical Technology & Healthcare, Quality Assurance, Quality Checking, Quality Complaints, Quality Consulting, Quality Control, Quality Management system, Quality Monitoring, Quality Services, Quality Training, Statistical Quality Control, Supplier Quality, tClinical/ medical writing /regulatory writing experience tFDA (510K) submissions tExcellent communication skills both written and verbal, tWorking experience in both Assay and Medical devices tWould have working experience in IVD industries,

Keyskills :
ltdiso 14971accountancysalesmisfinance

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