Software Quality Assurance Analyst IRC282351

職種概要

Our client is a global medical technology organization focused on digital surgery and robotic-assisted systems. It provides an FDA-cleared surgical platform used internationally and is developing a next-generation robotic solution

必要条件

• 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 assosiated 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 experiance in review of related deliverables.
• Good understanding of Quality Management System standards (ISO 9001, ISO13485, FDA 21 CFR Part 820 and related)
• Experience of conducting or participating in internal/external quality audits.
• Bachelor’s or Marter’s Degree in engineering field is highly desirable.
• Ability to understands 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.

職務内容

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.

 

私たちが提供するもの

Culture of caring. At GlobalLogic, 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. 

Learning and development. 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 at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.

Interesting & meaningful work. GlobalLogic 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 shaping the world today.

Balance and flexibility. We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way!

High-trust organization. We are a high-trust organization where integrity is key. By joining GlobalLogic, you’re placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.

GlobalLogicについて

GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.