Device SW/ IT QA Engineer

Primary purpose and function of this position:
• Develop an understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP areas
• Participate in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk based approach based on GAMP 5
• Develop, revise, and maintain  IT related validation documents to ensure system hardware and software are in compliance with all relevant regulations policies and procedures 
• elements  throught the einter product life cycle . 
• Estimate, prioritize, plan and coordinate SW testing activities
• Monitor SW debugging process results
• Investigate the causes of non-conforming software and train users to implement solutions
• Stay up-to-date with new testing tools and test strategies 
• Track quality assurance metrics, like defect densities and open defect counts
• Validate the testability of requirements and compliance to requirements of application software designs
Required Education & Experience
• BS/MS degree in Computer Science, Engineering or a related subject.
• 3+ years SW QA experience in supporting a medical device development and manufacturing environment.
Required Knowledge, Skills & Abilities: 
• Proven work experience in software development
• Proven work experience in software quality assurance
• Strong knowledge of software QA methodologies, tools and processes
• Experience in writing clear, concise and comprehensive test plans and test cases
• Hands-on experience with both white box and black box testing
• Hands-on experience with automated testing tools
• Solid knowledge of SQL and scripting
• Experience with performance and/or security testing is a plusStrong interpersonal, communication, analytical and complex problem solving skills.
• The ability to develop partnerships and influence.
• Ability to work independently and has strong team building skills.