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Quality Assurance

Chandigarh, Punjab

Classic Informatics

Job Description

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

Company Description

Classic Informatics is a global web development and mobile apps development agency with over... 150 techies and designers on-board.  Read full description

Additional Information

Last updated:
Job type:
Full time
Position type:
Minimum experience:
One year
Compulsory Education
Jobs in Quality / Testing / Process Control
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