5 - 10 years of experience in Medical/Life Sciences industries software testing.
Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA
High-level strategic problem solving and reasoning skills. Analyzes evaluate and present information concerning findings, trends with IT in business, and development.
Ensure the adherence of software validation processes and perform review & approval for all the software validation activities.
Suggests and debates to implement the right SDLC, software validation methods, and procedures with the Flex.
Here are a few of our preferred experiences:
Software validation experience in the medical/medical device industries.
Knowledge in test automation tools.
Bachelor’s degree in related field or equivalent experience.
Knowledge in CSA
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