Sr. S/W Quality Engineer

Bachelor's level degree in Science/Engineering/Software discipline 6 years of related experience, including 3+ years' experience in Software Quality and validation Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices Must have good understanding of quality system requirements and how each quality system element connects Some experience in working with ‘Agile' software development and validation methodologies Some experience/knowledge of work management and testing tools (such as JIRA, Xray, qTest) Experience working with a diverse population of internal and external customers Comfortable speaking and presenting to leadership Strong written and verbal communication skills Creative and innovative thinking skills Experience managing projects and project deliverables to completion Comfortable working independently and as part of a cross-functional team Ability to manage multiple priorities and work without ambiguity People leadership experience a preference