BioTalent · 2 days ago

Software Quality Engineer 2

San Diego, CA

Full-time

Onsite

Mid Level

2+ years exp

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Responsibilities

Provides quality support for software project teams throughout the software lifecycle, from design through launch.

Ensures quality integration into the overall functions of software development, scientific computation, and data acquisition.

Creates and reviews various software lifecycle project deliverables based on procedural requirements.

Performs risk analysis and is responsible for risk management activities: determines, evaluates and documents software risks from product design to post-launch.

Analyzes test results to ensure existing functionality and requirements are met, and if necessary, recommends corrective action.

Provides traceability analysis and traceability reports to ensure project requirements have been met.

Participates on the Software Review Board (SRB) to evaluate and disposition software anomalies.

Reviews and approves Change Orders as well as provides quality input to support closure (QMS updates, Procedural changes).

Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable.

Qualification

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Quality ManagementRegulatory ComplianceFDA RegulationsISO 14971IEC 62304Problem-SolvingTeamworkCommunicationMobile App Technologies

Required

Bachelor's degree in Engineering, Computer Sciences or related field

2+ years of experience acting as a Quality representative on software projects and guiding cross-functional teams towards compliance in an FDA-regulated industry

Strong knowledge of federal and other regulations including QSRs, ISO 14971, IEC 62304