Elite Technical is looking for a highly skilled Quality Assurance Testing expert with FDA experience.
Our client develops software to assist with their customers' Next Generation medical device platforms and instruments.
These platforms and instruments provide -breakthrough- technologies that are used to diagnose cancer and other diseases, develop personalized medicines, provide gene sequencing, and perform research to assist with developing other healthcare solutions.
The successful candidate will have experience generating test cases from requirements documents for medical instruments. The candidate will execute test cases and generate execution reports. The candidate must have experience with requirements for evidence gathering necessary for FDA 510K submissions. Additionally, they need to have some experience with lab equipment
The majority of our client's customers develop medical devices regulated by the FDA. The successful candidate must have experience with FDA 21 CFR Part 820 - Quality System Regulation and IEC 62304 Software Development Lifecycle.
* Must have experience w/ requirements for evidence gathering necessary for FDA 510k submissions
* Must have experience with FDA 21 CFR Part 820- Quality Systems Regs
* Must have experience with IEC 62304 Software Development Lifecycle
* Exp writing test cases - 1/3 of the job
* Exp executing test cases - 2/3 of the job
* Exp creating and using a test matrix
* Exp with defect tracking and management
* Quality systems ( ISO 14971, ISO 9000, IEC 63xxx
* 2 year related AS degree required
* minimum 2 years of experience
Monday, April 12, 2021
Tuesday, March 23, 2021
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