Senior Advance Quality Engineer
Stryker
Gurugram, Haryana
6d ago

Responsibilities

  • Conduct Risk Management per ISO14971 to ensure the safety and effectiveness of product.
  • Conduct design reviews & risk management reviews as required during various project phases.
  • Work with R&D during Electrical / Embedded developments (Electrical & electronic hardware development and Software development) to provide inputs w.r.t quality & safety.
  • Participate and conduct DHF / DMR Reviews for Electrical / Embedded developments
  • Support in V&V to ensure product compliance, safety, reliability & effectiveness.
  • Support to conduct CSV / Process Validation as required.
  • Technical Skill Set

  • Practical implementation of Risk Management of Medical Device per ISO 14971.
  • Experience with Risk Analysis tools and techniques.
  • Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304.
  • Experience on Medical Device Electrical / Electronic Hardware Development Life Cycle Process (HDLC).
  • Understanding of electrical & embedded component’s working principle and functionality.
  • Understanding of various documentation required during HDLC & SDLC.
  • Familiarity with IEC 60601-1 family of standards.
  • Familiarity with any basic programming language, embedded software & tools.
  • Understanding of Quality Management Systems for Medical Devices. (ISO 13485, 21 CRF 820).
  • Work From Home : NoTravel Percentage : None

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