Quality Systems Engineer – Internship… at DEKA Research… · Manchester

Summary: DEKA Research and Development is offering an exciting internship opportunity for a Quality Systems Engineer Intern in Manchester, NH. The intern will work alongside engineers to enhance DEKA's Quality Management System by designing workflows, reviewing documentation, and supporting regulatory compliance activities. Responsibilities: - Designing and testing workflows in the electronic QMS (eQMS) platform - Reviewing SOPs and documentation for alignment with FDA QSRs, ISO 13485, and other regulatory standards - Supporting CAPA investigations using root cause analysis, data-driven insights, and structured problem-solving approaches - Conducting a regulatory research review of SOPs scheduled for 2027 periodic review — evaluating current regulations and standards to identify gaps, and drafting gap assessments and remediation plan proposals - Collecting, analyzing, and trending quality data to support metrics reporting - Writing and refining SOPs, operating procedures, and guidance documents that support QMS processes - Streamlining and formatting quality documents for improved usability and traceability - Building an Excel-based compliance map tracing relationships between SOPs, Quality Handbooks (QHs), and Operating Procedures (OPs) - Supporting software tool validation activities under supervision, including contributing to automated testing development alongside a QMS software engineer - Reviewing design control phase transition records (QH161) to verify all required elements are addressed - Supporting document scanning and general QMS administrative tasks (estimated 5–10 hours/week) Required Qualifications: - Enrolled in an undergraduate science or engineering program (graduate students are not eligible) - Local to New Hampshire (preferred) - Must have strong attention to detail Preferred Qualifications: - Exposure to or coursework in the following areas is a plus (preferred): - Biomedical engineering or design projects - Design controls or medical device regulations (21 CFR Part 820, ISO 13485) - Microsoft Word and Excel - Technical documentation (e.g., lab reports, procedures) Required Skills: Biomedical engineering, Design controls, ISO 13485 Important Skills: Microsoft Word, Microsoft Excel Nice-to-Have Skills: Analytical thinking, communicator, Curiosity & drive Internship Start Date: Start in 2026 Summer