Elite Technical is looking for a Senior Verification lead to have an immediate impact with a firm that develops specialized software engineering dedicated to the FDA regulated medical device market.
Our client develops software to assist with their client's 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 in a leadership position on a software team. The Verification Lead-s role will be to establish the verification test plan, maintain the requirements trace matrix, and oversee the development of the test cases and test execution. The Verification Lead will be responsible for the creation of verification tests and the approval of the verification tests written by other team members.
The Verification Lead will also be responsible for estimating and tracking verification tasks against the project schedule.
The Verification Lead will be expected to work with the Project Manager and the software development team to assure quality releases are delivered on time to meet our client's needs.
The majority of our client's customers develop medical devices regulated by the FDA. The successful candidate will be familiar with the FDA 21 CFR Part 820 - Quality System Regulation. Knowledge of GxP documentation is required. The successful candidate will be able to adapt to the unique challenges of software used with medical devices.
* Some type of prior "lead" experience on a software team
* Familiarity with FDA 21 CFR part 820-quality Systems Regs
* GxP documentation exp
* Experience writing test plans
* Experience creating and maintaining a trace matrix
* Experience writing, reviewing and approving test cases
* Experience executing tests and approving executed test cases
* Experience with defect tracking and management
* 4 yr related degree
* Minimum 6 years of experience
Monday, April 5, 2021
Monday, March 15, 2021
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