Quality Assurance Analyst

Validate medical devices, engineering test fixtures, custom software programs and off-the-shelf software packages with special emphasis on document preparation and testing.
REQUIREMENTS
·Assist all departments in requirements gathering and with the preparation of validation documents.
·Write technical engineering, system and database design documents.
·Assist with software code reviews.
·Write, review and execute verification and validation test protocols for application software, database software, medical device components and test fixtures.
·Perform software and infrastructure risk assessments.
·Assist in the creation of SOPs.
·Assist in internal and vendor audits.
·Provide SOP and software-specific training.
·Support the organization’s quality management system by monitoring compliance with SOPs, and by providing advice and expertise in the areas of verification and validation.