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Advance Quality Engineer (SW) in Gurugram bei Stryker Corporation

Datum der Veröffentlichung: 5/22/2019

Stellenauszug

Stellenbeschreibung

Will work within the new product development team, with responsibilities including, but not limited to the following:

  • Developing software according to SDLC with primary points of focus on planning, defining requirements, testing, and deployment.
  • Perform Risk management, develop risk control measures and test strategies, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File
  • Co-develops software solutions by conducting research to understand user needs, data usage, systems flow, work processes, problem areas and bug reporting, and driving good code practices.
  • Provide engineering input to impact the design, coding and debugging of software in various coding languages including SOUP software.
  • Performs software analysis, code analysis, requirements analysis, software review, identification of code metrics, system risk analysis, and software reliability analysis
  • Performs Software build, Maintenance, and change control. Maintains software configuration management in Perforce.
  • Lead project team through Software Defect Management in all phases of development. 
  • Collaboration with other engineering disciplines, such as electrical, mechanical and industrial design, to ensure that embedded software will accomplish design goals for a particular product or system.
  • Help guide New Product Development teams through quality system to ensure software is developed in compliance to internal procedures as well as the requirements of the FDA, ISO, and other regulatory bodies, which may include: FDA, ISO 13485, ISO14971, FDA 21 CFR Part 11, FDA 21 CFR 820.30, ANSI AAMI IEC 62304:2006, IEC 60601-1-2: 2007 and FDA General Principles of Software Validation GPSV requirements
  • Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products.
  • Communicates effectively with team and management to drive project efficiency and status of progress with a focus on solutions.
  • Knows and applies fundamental and some advanced concepts, practices and procedures of practical field of specialization.

Work From Home: No

Travel Percentage: None

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