Software Quality Engineer

The Software Quality Engineer conducts continuous Improvement Reviews, conducts root cause analysis on specific project areas, determines the need for - and provides - QSR compliance and SQA support, ensures appropriate review of software products, identifies and documents noncompliance, implements improvements in processes, standards, and procedures, Monitors quality of software products, processes, and standards, Performs in-process and phase end assessments, Provides Part 11 compliance support, recommends improvements in processes, standards, and procedures, supports SW development validation lifecycle, facilitates and participates in qualification of acquired SW and SW tools.

Send MS Word Resume to softwareteam@entegee.com and reference job#458653rw. This is not a position for which the employer will provide sponsorship for employment visa status.

Job Duties: Demonstrated experience in product risk management according to ISO 14971. Understanding requirements management & tracing, defect tracking, configuration management techniques and how they can be applied in the software development cycle. Familiar with current Software Quality Assurance techniques, Software industry standards. Ability to understand and apply Medical Device Design Control to software development & validation. Request Notes: Demonstrated project management and leadership skills. Ability to write technical reports, technical procedures and administrative procedures. Temp to Hire 3 to 6 months. Job location in Northridge, CA.

TOP 3 SKILLS: 1.Risk Management 2. System Level Planning 3. Root Cause Analysis responsible for the quality and reliability of software used in products, development, manufacturing processes, and implementation of the quality systems.

Requirements:
** QSR compliance and SQA support
** Software Review
** 21 CFR Part 11 Compliance support
** Performs in-process and phase end assessments
** Supports SW development Validation lifecycle
** Demonstrated experience in product risk management according to ISO 14971
** Software Quality Assurance techniques
** Medical Device/Pharma industry experience