Software Quality Engineer (Validation & Quality)

United Consulting Hub is seeking an experienced Software Quality Engineer (Validation & Quality) to support software quality assurance, validation, and compliance activities within a regulated medical device environment. The role involves ensuring compliance with FDA regulations and collaborating with various teams to maintain quality standards.

Responsibilities:

• Support software quality assurance and validation activities for medical device software systems
• Develop, review, and execute validation documentation including:
• IQ/OQ/PQ Protocols
• Test Plans
• Validation Reports
• Traceability Matrices
• Support software design controls and remediation activities
• Collaborate with Software Engineering, Quality, Regulatory, and Validation teams
• Ensure compliance with FDA regulations, IEC 62304, ISO 13485, and company quality standards
• Support risk management, CAPA, deviation, and change control activities
• Participate in software verification and validation (V&V) testing
• Maintain audit-ready documentation and quality records

Requirements:

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related field
• Strong experience in software quality engineering and validation within the medical device industry
• Hands-on experience with: Software Validation, Design Controls, SDLC Documentation, Verification & Validation (V&V), Risk Management
• Strong understanding of: FDA regulations, IEC 62304, ISO 13485, 21 CFR Part 11
• Excellent technical writing, analytical, and communication skills
• Ability to work independently in a remote environment
• Experience supporting remediation or compliance-driven projects
• Familiarity with CAPA, change control, and DHF documentation
• Experience with Agile or regulated software development environments
• Knowledge of cybersecurity or SaMD (Software as a Medical Device) is a plus