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QA Software Engineer

Company Name:
Leddy Group
Leddy Group is seeking a QA Software Engineer in Scarborough.
Essential Duties and Responsibilities
Work with software engineers throughout the software development life cycle to ensure compliant implementation of medical device software as well as Quality and Manufacturing software systems.
Responsible for planning and executing verification activities, including review and evaluation of documents, design, code, requirements, and specifications.
Responsible for software validation activities and documentation
Assist in quality assessments of product and development practices during all phases of product development to ensure compliance with all FDA requirements.
Help to conduct audits of external contractors and technology providers.
Work closely with Development and Project Managers to help define, spec, implement and validate a project from start to finish.
Education and/or Experience
5+ years of software QA experience in a regulated environment
BS Degree in Engineering required. Software Engineering or Industrial Engineering Preferred.
Working knowledge of ISO13485, FDA QSR for medical device, and relevant international standards.
Solid understanding of software development life cycle (SDLC)
Experience in implementing processes and procedures to support ISO 62304
Experience with issue and problem management
Contact Leddy Group to apply. Email maine@ leddygroup.com or visit www.leddygroup.com

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