Provide ongoing software quality engineering support throughout the software development life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities.
The ideal candidate will be a proactive self-starter with a deep understanding of consumer devices, have a variety of experiences with embedded systems and possesses great attitude and communications skills.
Participate in all aspects of testing the CA PPM product. This includes participation in Agile grooming and planning meetings. Defect report creation and validation as well as functional and regression testing.
Participate in internal audits and supplier evaluations. Travel time is approximately 15 percent. Define and establish needed quality initiatives. Develop quality system procedures through cross-functional teams.
Provide guidance and Quality oversight ensuring suppliers are aligned with Clients, Regulatory and Industry standard requirements. Ensure controls meet Client, FDA, and other applicable regulatory requirements and identifying Quality needs, product/process improvements and customer requirements.
The Biological Assay Function within Roche/Genentechs Global Quality Organization is responsible for lifecycle management and technical innovation of post-BLA biological potency methods and specifications.
Analyzes and translates business requirements into system functional requirements and design for software systems and end-user training. Performs requirements gathering, analysis and user story and use-case development with internal and external customers for software delivery.