We are seeking a Sr. S/W Quality Engineer to develop, modify, and maintain standards for Software Quality methods, processes, and procedures that meet Boston Scientific and external regulatory requirements. The ideal candidate will have a bachelor's degree in Science/Engineering/Software discipline and 6 years of related experience, including 3+ years of experience in Software Quality and validation. The role requires expertise in software validation, quality philosophies, and principles, as well as strong written and verbal communication skills.
Requirements
- 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
- Experience 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
Benefits
- 401k Matching
- Retirement Plan
- Generous Paid Time Off
- Annual Bonus Target