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NaukriPosted on 2026-05-18
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Design Quality Assurance - Medical

Infosys

PuneFull time6-10 yearsNot disclosed

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25+Important JD
Keywords
doecapafmeadesignmedicalsix sigmausabilitycompliance + 17 more

Job Description

Educational Requirements
Bachelor of Engineering,Bachelor Of Technology
Service Line
Engineering Services

Responsibilities
Be a part of core project team and support the quality engineering across the entire development cycle
  • Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects.
  • 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 (DOE??s), FMEA sessions, Risk Management and ensure compliance to CTQ??s 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 why??s 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 13485 & 14971, 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->Medical Device
    Technology->Quality models/improvement frameworks->ISO 13485



    About The Company

    Infosys

    Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over three decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem. Visit www.infosys.com to see how Infosys (NYSE: INFY) can help your enterprise navigate your next.

    Company Size10000+
    Founded1981
    HeadquartersBangalore, Karnataka
    IndustryIT Services and IT Consulting
    TypePublic Company
    Websitehttps://www.infosys.com
    SpecialitiesIT Solutions and Services, Consulting, Business Process Outsourcing, Products and Platforms, Engineering Services, Cloud Services, Artificial Intelligence, Digital, and Big Data

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