Software Quality Assurance Analyst IRC282351

Join to apply for the Software Quality Assurance Analyst IRC282351 role at GlobalLogic.

Our client is a global leader in medical technology and advanced fiber‑optic‑based solutions, specializing in digital surgery and robotic‑assisted systems. GlobalLogic is partnering to develop the next‑generation surgical robotics platform.

Requirements

• At least 3 years of experience in a quality role within regulated industry such as medical device, aerospace/defense, automotive, or similar.
• Good understanding and practical application of medical device regulations (IEC 62304, ISO 14971, EU MDR for SaMD).
• Strong knowledge of Design Controls, Risk Management (FMEA, FTA), Root Cause Analysis, CAPA processes, auditing techniques (internal/external).
• Experience with SDLC models (Agile, Waterfall, Hybrid), software V&V methodologies, configuration management, change control, traceability tools.
• Proven experience reviewing and approving software lifecycle documentation and V&V artefacts.
• Understanding of CSV process and related deliverable review.
• Familiarity with QMS standards (ISO 9001, ISO 13485, FDA 21 CFR Part 820).
• Experience conducting or participating in internal/external quality audits.
• Bachelor’s or Master’s Degree in engineering (highly desirable).
• Strong communication skills, ability to explain complex quality details to non‑experts, manage competing priorities, and work cross‑functionally.
• Exceptional organizational skills.

Job Responsibilities

• Lead review and approval of project documentation (development plans, verification test plans, reports, etc.), ensuring timely preparation and readiness of deliverables.
• Review and approve CSV documentation.
• Assess project activities and deliverables against established QMS procedures, standards, and regulations.
• Advise R&D team on implementation or adjustment of processes.
• Collaborate with engineering, product, and support teams to ensure quality and accuracy of deliverables.
• Communicate with customers on quality assurance, process management, and documentation preparation.
• Ensure robust quality processes and regulatory compliance, contributing to patient safety and product effectiveness.

What We Offer

Culture of caring – inclusive environment where people first.

Learning and development – continuous growth with training and career tools.

Interesting & meaningful work – cutting‑edge projects that shape the world.

Balance and flexibility – explore work‑life balance options.

High‑trust organization – integrity and trust at our core.

About GlobalLogic – a trusted digital engineering partner for the world’s leading companies.