Design Quality Engineer

Atlantic Group; Massachusetts; On-site; USD 120,000 - 160,000; Full time

Job summary

Atlantic Group is seeking a qualified Quality Engineer to conduct comprehensive reviews and audits of Software Design History Files (DHFs) and related design documentation in a regulated environment. The role focuses on identifying gaps, traceability issues, and supporting remediation for legacy documentation.

The ideal candidate holds a Bachelor's degree in a technical field and has 5+ years in Quality Engineering or Design Controls, with experience in FDA-regulated medical devices or life

Qualifications

• Bachelor's degree in engineering, CS, bioengineering, life sciences, or related field.
• Minimum 5+ years in Quality Engineering or Design Controls within a regulated industry.
• Experience with FDA-regulated medical devices or life science products.

Responsibilities

• Conduct detailed reviews and audits of 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.

Education

Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Life Sciences, or related technical discipline

Quality Engineering, Design Assurance, Software Quality, or Design Controls

Job description

• 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.