Quality Engineer - Medical Devices

Quality Engineer - Medical Devices

Posted by Infosys

Gurugram

Posted: imported by Jeevika

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Lead the development and implementation of design verification and validation plans with project design lead. Lead the development of Critical to Quality (CTQs), design input and output documents. Lead the fixture qualification and test method validation. Participate and implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management and ensure compliance to CTQs and safety requirements. Manage electronic document control and version control on all project related documents. Ensure adherence to the quality systems and design assurance SOPs. Lead usability, reliability, testing, verification and validation testing internal and local vendors. Provide statistical testing and reliability plans. Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution. Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable). Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 whys analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality. Technical and Professional Requirements QMS Knowledge of Regulatory standards CFR820, ISO [hidden], 60601 Hands on experience on Risk Management. Good understanding of Post Market Survey and complaint handling. Design plan Medical Process DQC Deviation and CAPA preferred. Preferred Skills Foundational- Development process generic- Medical Device development process Technology- Quality models/improvement frameworks- ISO 13485 Role: Quality Engineer,Industry Type: IT Services & Consulting,Department: Quality Assurance,Employment Type: Full Time, PermanentRole Category: Production & ManufacturingEducationUG: Any GraduatePG: Any Postgraduateread moreKey SkillsSkills highlighted with ‘‘ are preferred keyskillsQuality EngineeringQuality AuditQuality ManagementMedical DevicesSupplier Quality AssuranceEngineeringQcProcess InspectionQualityQmsQuality AnalysisProductionQuality CheckManufacturingQuality AssuranceQuality ControlAbout the companyInfosys IT Services & ConsultingFortune India [hidden])Highly Rated by WomenTOPServiceFollow2070.5k followers OverviewInfosys is a global leader in next-generation digital services and consulting. Over 323,000 of our people work to amplify human potential and create the next opportunity for people, businesses and communities.We enable clients in 59 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer clients, as they navigate their digital transformation powered by cloud and AI.We enable them with an AI-first core, empower the business with agile digital at scale and drive continuous improvement with always-on learning through the transfer of digital skills, expertise, and ideas from our innovation ecosystem.We are deeply committed to being a well-governed, environmentally sustainable organization where diverse talent thrives in an inclusive workplace.Visit [hidden] to see how Infosys (NSE, BSE, NYSE: INFY) can help your enterprise navigate your next. read moreExplore Life at InfosysInspiration, Opportunity, and Community. Join Infosys for all this and moreRestart With InfosysWe are deeply committed to being a well-governed, environmentally sustainable organization where diverse talent thrives in an inclusive workplace.Company InfoLink:Infosys websiteAddress: BengaluruBeware of imposters! Naukri.com does not promise a job or an interview in exchange of money. Fraudsters may ask you to pay in the pretext of registration fee, Refundable Fee…Read moreInfosys rolesyou might be interested inPower Bi+DAX- @Infosys7-9 YrsHybrid - Pune, Delhi / NCR, Mumbai (All Ar...Posted 2 Days AgoPega Developer(9-11yrs)-@infosys9-11 YrsHybrid - Pune, Delhi / NCR, Mumbai (All Ar...Posted 2 Days AgoPega Developer(9-11yrs)-@infosys9-11 YrsHybrid - Pune, Delhi / NCR, Mumbai (All Ar...Posted 2 Days AgoKey highlights at InfosysJob SecurityHighly ratedWork LifeHighly ratedCompany CultureHighly ratedAwards & Recognitions2026Infosys awarded the Global Top Employer 2026 certification in 20 countries, across Asia Pacific, Europe, the Middle East, and North America.2025Infosys has won the GPTW recognition 2025-26 for the fifth year in a row in India and China.2025Infosys has been recognized among India's Best Employers Among Nation Builders 2025 by Great Place To Work®2025Infosys recognized as a Top 100 most valuable brand in the world by Kantar BrandZ and ranked among the most-trusted brands in India and the US.2025Infosys recognized as one of the World’s Most Ethical Companies in 2025, for the Fifth Consecutive Year by Ethisphere.2025Infosys has been recognized as the largest IT employer in Karnataka at the Invest Karnataka 2025 Summit.2025Brand Finance Recognizes Infosys as Top 3 IT Brand, Fastest Growing GloballyCompany verified benefitsView allFlexible Working HoursWe're strictly lenient about your working hours. We trust you to know how to maximize your... read more5 Days WorkingWe believe in the importance of personal space and encourage work-life balance. Keep the w... read moreReviewsView all52.2K employee reviews5.0rated by Quality Analyst in PuneHave learned lot of technical things as well as non technical such as how to work with the clientsRead full reviewFollow Infosys to receive the latest job postings and alerts2068.2k followersPowered bySalary insightsQuality Engineer in Infosys typically earns between₹7.8 - ₹8.6 L/yrSee detailed salary breakupPowered byBenefits & PerksView all5K employees reported these benefitsHealth & Wellness SupportLearning & Development SupportTransport / Travel SupportFree MealPerformance BonusRelocation AssistancePowered by

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