Senior Software Quality Engineer
Job in
Quincy, Norfolk County, Massachusetts, 02171, USA
Listed on 2026-07-08
Listing for:
United Pharma
Part Time
position Listed on 2026-07-08
Job specializations:
-
Software Development
Software Testing, Software Engineer, Software Project Mgr/ Lead, DevOps
Job Description & How to Apply Below
Senior Software Quality Engineer
Location:
Massachusetts (100% Onsite, with potential for 1 day/week remote)
We are seeking an experienced Senior Software Quality Engineer to support software quality initiatives within a regulated Medical Device environment. This role will partner closely with Software Engineering, Quality, and Regulatory teams to ensure compliance throughout the Software Development Life Cycle (SDLC). The ideal candidate will have strong expertise in software quality, regulatory compliance, documentation review, and software validation while ensuring adherence to FDA regulations and IEC 62304.
Key Responsibilities- Partner with Software Engineering teams to ensure quality and compliance throughout the Software Development Life Cycle (SDLC).
- Review and approve software quality documentation, including software requirements, test protocols, test reports, verification and validation documentation, and risk management files.
- Ensure compliance with FDA regulations, IEC 62304, and internal Quality Management System requirements.
- Participate in software risk management activities and documentation reviews.
- Drive continuous improvement efforts to enhance software development and quality processes.
- Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
- 5+ years of Software Quality Engineering experience in the Medical Device industry.
- Strong experience supporting Software Development Life Cycle (SDLC) activities.
- Experience reviewing and approving software quality documentation.
- Working knowledge of FDA software regulations and IEC 62304.
- Strong understanding of software verification, validation, and risk management.
- Excellent communication and cross-functional collaboration skills.
- Experience with Software as a Medical Device (SaMD).
- Knowledge of software cybersecurity within regulated environments.
- Experience with CAPA, internal audits, risk management, and broader Quality Management Systems.
- Familiarity with FDA design controls and software validation requirements.
Position Requirements
10+ Years
work experience
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