Design Quality Engineer
Job in
Worcester, Worcester County, Massachusetts, 01609, USA
Listed on 2026-09-25
Listing for:
Atlantic Group
Full Time
position Listed on 2026-09-25
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
- 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.
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