Senior Software Quality Engineer

A company is looking for a Senior Software Quality Engineer to support the validation of non-product software systems and tools within the quality management system.

Key Responsibilities

Support software validation and verification to ensure compliance with FDA regulations and industry standards

Oversee the quality approval process for software components, including documentation review and release approvals

Collaborate with cross-functional teams to support overall non-product software lifecycle management

Required Qualifications

Bachelor's degree in life sciences, engineering, or math preferred; or equivalent combination of education and experience

5+ years of quality experience in the pharmaceutical, biotech, or medical device industries

3+ years of experience in non-product software validation within an FDA-regulated environment

Strong understanding of FDA regulations, ISO 13485, and 21 CFR Part 11

Experience with auditor interaction in internal quality audits and regulatory inspections