Senior Design Quality Engineer - DHF & Compliance
Atlantic Group
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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
Job description
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
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