Design Quality Engineer
Atlantic Group
Conduct detailed reviews and audits of existing Software Design History Files (DHFs) and related design documentation. Identify documentation gaps, inconsistencies, missing approvals, incomplete records, and traceability issues. Support remediation efforts for legacy software design and development documentation. Research, reconstruct, and organize historical design records when necessary. Review documentation for alignment with established design control processes and internal quality procedures. Maintain accurate and organized documentation throughout remediation activities. Collaborate with engineering and quality teams to resolve documentation deficiencies and close identified gaps. Required Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Life Sciences, or related technical discipline. 5+ years of Quality Engineering, Design Assurance, Software Quality, or Design Controls experience in a regulated industry. Strong understanding of Design Controls and Design History Files. Experience supporting FDA-regulated medical device, IVD, diagnostics, or life science products. #J-18808-Ljbffr
Vacancy posted 1 day ago
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