Develop and maintain standards for software systems quality operating methods, processes, and procedures to ensure product quality and compliance with project, process, and contract requirements and objectives.
Requirements
- Experience with Risk management documentation: pFMEAs
- Basic knowledge in PLC, general programming, Source Code Review
- Basic knowledge in Root Cause Analysis
- Basic knowledge in designing validation strategies
- Knowledge in Medical Devices regulations
- Knowledge in GAMP
Responsibilities
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation
- Defines appropriate measures to ensure product quality
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements
- Provides or directs verification and validation of software system requirements, traceability, and testability
Other
- University Degree and minimum of 3 years of relevant experience, or advanced degree with a minimum of 1 years relevant experience
- May act as a mentor to colleagues or may direct the work of other lower level professionals
- May be responsible for entire projects or processes within job area
- Communicates with senior internal and external customers and vendors
