BioTelemetry Research - Validation Engineer
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POST DATE 9/17/2016
END DATE 3/28/2017
The Validation Engineer is responsible to insure that software and other enhancements to VirtualScopics systems meet customer requirements in a manner that is consistent with all regulatory and VirtualScopics needs.
* Coordinate validation activities (including software); ensure constant communication with affected departments and personnel.
* Provide leadership in the company s validation planning and execution processes.
* Manage and review validation area processes and procedures.
* Support validation program, change management and revalidation requirements.
* Develop validation plans and reports to support software platform releases, automated tasks, off-the-shelf software implementation and other tasks as specified in the Change Control Board (CCB) meetings and/or by management.
* Work with other departments to ensure effective validation planning: define and execute specific validation protocols (software, test method and process validation).
* Ensure regulatory compliance in validation processes with FDA 21 CFR Part 11, QSR and ISO 13485 regulatory requirements.
* Use quality tools to determine risk analysis and validation requirements.
* Develop, implement and monitor validation metrics.
* BS in Engineering, scientific or a related technical discipline.
* Minimum 3+ years of experience in software validation or verification.
* Familiarity with Defect Tracking System.
* Familiarity with SQL databases a plus.
* Ability to prepare protocols and reports necessary for assigned validation work.
* Skilled at interfacing well with others.
* Proficient at MS-Word and Excel.
* Strong communication (written/verbal) skills.
* Ability to communicate at multiple levels of an organization.
* Ability to organize and judge priorities.
* Ability to generate and maintain accurate records.
The company is an equal opportunity employer.
Cardiocore Biotelemetry Research