· Authorship and review/approval level involvement on documents, such as Planning, Requirements, Test Plans, System Testing.
· Prepare all documentation in accordance with FDA regulations including 21 CFR Part 11.
· Creating new templates updating and revising Supplier Quality Agreements and quality requirement.
· Develops new techniques, test protocols.
· Working with Systems Engineers on defect resolution and management.
· Perform detail risk assessment based on patient safety, product quality and data integrity.
· Involve in continuous improvements of Supplier Quality Agreements and quality requirement.
This position requires a minimum of Bachelor’s degree in Computer Science or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in Computer Science or a closely related field.
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