Computer System Validation Engineer

The Software Quality Engineer will not be a tester or a coder. The most important qualification is experience in computer systems validation (CSV) in GXP FDA-regulated environments. Since JJVC is an FDA regulated company, the SQE needs to ensure all computerized systems are in compliance with GXP requirements for medical devices from FDA and other national health authorities.

The Software Quality Engineer is a QA role that needs to provide direction / guidance to testers on how to write appropriate test scripts, how to manage test defects, and will be reviewing and approving those tests scripts (and test defects), and the corresponding test executions.

The SQE will also provide guidance, reviews, approvals for other CSV document deliverables such as User Requirements Specifications, Design Specifications, Requirements Traceability Matrices, Validation Plans, Validation Reports, Risk Assessments, Data Integrity assessments, eRecords / eSignature assessments, etc.

The system this person will support is a custom Distribution Control System, used to manage our global Distribution operations. CSV experience with ERP systems such as SAP is close enough.