Software Quality Assurance Analyst IRC

Description

Our client is a global leader in medical technology and advanced fiber optic‑based solutions, specializing in digital surgery and robotic‑assisted systems.

Global Logic is partnering with this organization to develop their next‑generation surgical robotics platform. The client already provides an FDA‑cleared surgical platform used internationally, but the project is focused on building its successor—an innovative robotic solution designed to set new standards in precision and patient care.

• At least 3 years of experience in a quality role within the medical device, aerospace/defense, automotive or similar regulated industry.
• Good understanding and practical application of medical device regulations or respective regulations in associated regulated industry (e.g. IEC 62304, ISO 14971 and EU MDR requirements for SaMD).
• Good understanding of Design Controls, Risk Management techniques (FMEA, FTA), Root Cause Analysis, CAPA processes, Auditing techniques (internal/external) practical application.
• Good understanding of SDLC models (Agile, Waterfall, Hybrid), Software V&V methodologies, Configuration Management principles, Change Control processes, Traceability tools/techniques.
• Good proven experience of reviewing and approving software lifecycle documentation and V&V artefacts.
• Good understanding of Computer System Validation (CSV) process and experience in review of related deliverables.
• Good understanding of Quality Management System standards (ISO 9001, ISO
  13485, FDA 21 CFR Part 820 and related)
• Experience of conducting or participating in internal/external quality audits.
• Bachelor's or Master’s Degree in engineering field is highly desirable.
• Ability to understand and subsequently explain complex quality details to non‑experts.
• Excellent written and verbal communication skills.
• Ability to work effectively cross‑functionally and manage competing priorities.
• Exceptional organizational skills.

• Leading review and approve of project documentation (such as development plans and reports, verification test plans and reports etc.), providing feedback and support team in order to ensure timely preparation and readiness of project deliverables;
• Review and approve of CSV documentation;
• Assessing project activities and deliverables against established procedures, standards and regulations as per established QMS;
• Advising R&D team regarding implementation or adjustment of established processes;
• Work closely with engineering, product, and support teams to ensure the quality and accuracy of project deliverables;
• Communicating with a customer on quality assurance, process management, documentation preparation topics;
• You will collaborate with R&D and product management teams to ensure robust quality processes and regulatory compliance;
• This role is critical for ensuring patient safety, product effectiveness, and successful regulatory submissions.

At Global Logic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you'll experience an inclusive culture of acceptance and belonging, where you'll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders.

We are committed to your continuous learning and development. You'll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career h our Career Navigator tool as just one example, Global Logic offers a rich array of programs, training curricula, and hands‑on opportunities to grow personally and professionally.

Global Logic is known for engineering impact for and with clients around the world. As part of our team, you'll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem‑solving skills as you help clients reimagine what's possible and bring new solutions to market. In the process, you'll have the privilege of working on some of the most cutting‑edge and impactful solutions…