Software Engineer

Software Quality Engineer

About KKR Consulting

KKR Consulting is a specialized life sciences consulting firm delivering high-impact expertise across Quality, Software Engineering, Regulatory, Manufacturing, Validation, and Technical Operations. We support global pharmaceutical and medical device organizations by providing expert-driven solutions that strengthen compliance, enhance product development, and optimize operational efficiency. Our consultants are trusted partners who help organizations build scalable, audit-ready, and future-focused Quality Management Systems aligned with industry and regulatory standards.

Key Highlights

• Join a lean, cross-functional development team supporting software quality oversight for medical device development.
• Lead development of software quality processes and procedures aligned with ISO 13485, 21 CFR 820, and IEC 62304.
• Provide Quality representation throughout design verification, validation, requirements development, testing, and risk management.
• Support the design and implementation of QMS elements, ensuring alignment with company goals, compliance expectations, and KKR Consulting methodology.

Key Responsibilities

• Develop, implement, and maintain software quality processes and procedures supporting design controls, V&V activities, configuration management, and risk management.
• Collaborate closely with R&D to review protocols, test cases, user requirements, and design specifications from a software Quality perspective.
• Provide Quality representation in design and development activities, ensuring compliance with ISO 13485, 21 CFR 820, IEC 62304, and internal Quality standards.
• Participate in and support risk management activities, ensuring proper hazard identification, risk analysis, risk control, and traceability.
• Support and oversee device design verification and validation strategies, planning, and execution to ensure regulatory-ready documentation.
• Lead the authoring, development, and rollout of Quality Management System (QMS) elements, including SOPs, work instructions, templates, and process maps, aligned with company goals and continuous improvement initiatives.
• Contribute to QMS implementation through cross-functional training, documentation updates, and identification of process gaps and improvement opportunities.
• Ensure all quality activities adhere to regulatory requirements and industry best practices for medical device software lifecycle management.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline.
• Experience supporting software quality and design controls in a medical device or regulated environment.
• Strong working knowledge of ISO 13485, 21 CFR 820, IEC 62304, and related Quality and software development standards.
• Experience with verification, validation, risk management, and software lifecycle documentation.
• Ability to work effectively in a lean, cross-functional environment and represent Quality in technical discussions.
• Excellent written and verbal communication skills; capable of influencing stakeholders and driving Quality initiatives.