Stryker Senior Advance Quality Engineer in Gurugram, India
· 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: No
Travel Percentage: None
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com
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