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Job: Quality Analyst


Quality Analyst

Job Profile : Quality Assurance / Testing
Job Location : Chandigarh
Job Type : Permanent
Number of Openings : 2
Relevant Experience Required : 1 – 5 years
Job Responsibilities:
  • Analyze System and Software requirements to determine testability, completeness and consistency.
  • Experience of building and testing applications for medical devices is MUST
  • Follow established standard operating procedures.
  • Knowledge of standard IEC 62304 Medical Device Software Software life cycle process.
  • Experience ensuring compliance to ISO 13485, FDA QSR and applicable standards
  • Understanding of FDA 21 CFR 820 and ISO 13485 requirements and knowledge of ISO 14971 and IEC 62304
  • Develop test objective and design test protocols by performing in-depth requirements analysis.
  • Assess the need to automate tests and develop either automated or manual test scripts.
  • Database testing good to have.
  • Provide solutions to a variety of technical problems of large scope and complexity.
  • Compile data and define changes required in testing equipment, testing procedures, or new testing requirements.
  • Provide inputs for test equipment capabilities.
  • Provide traceable evidence between requirements and tests.
  • Write formal test plans, report documentation of activities that can be used in submission packages to regulatory agencies.
  • Follow established standard operating procedures.
  • Experience with OpenGL and image processing capabilities
  • Knowledge of Software and System Architectures, Software Engineering Best Practices, and programming and scripting languages.
  • Experience using configuration management tools, requirements management tools, and defect tracking systems.
  • Ability to interpret specifications and apply to test setups and various devices

Requisite Skills: 

  • Bachelor’s degree in Engineering or Computer Science
  • Minimum 1-3 years experience with software quality assurance, preferably in the medical device industry, with a strong Understanding of the software development cycle
  • Understanding of FDA 21 CFR 820 and ISO 13485 requirements and knowledge of ISO 14971 and IEC 62304
  • Eager to engage in product development, hardworking and enjoy a challenge
  • Commitment to quality and attention to detail
  • Good English communication skills