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BioTelemetry Research - Validation Engineer 9/17/2016

Cardionet Inc. Rochester, NY

Company
Cardionet Inc.
Job Classification
Full Time
Company Ref #
2016-2291
AJE Ref #
576203373
Location
Rochester, NY
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
OVERVIEW:

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.

RESPONSIBILITIES:

* 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.

QUALIFICATIONS:

* 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.

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* 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.

COMPANY:

Cardiocore Biotelemetry Research