Middle Design Quality Assurance / Tool Validation Engineer IRC270201

Description

Our client is innovative manufacturer of medical devices in the United States which produces a devices and software applications.

At this project, you will have a great opportunity to be involved into the full development life cycle of medical software which is intended to help individuals by processing certain information taken from medical devices to identify health trends and to track daily activities.

Requirements

• At least 1-3 years of IT industry experience (Software Quality Assurance Engineer/Analyst/process engineer or similar position from Quality Assurance or Process Management sphere) or as a quality/certification/process/metrology specialist in other domains is a must;
• Strong knowledge, deep understanding and practical application (implementation, support) of international quality management system standards and regulations (e.g. ISO 9001:2015, ISO 13485);
• Experience in auditing/assessment of Quality Management System based on international quality management system standards (e.g. ISO 9001:2015, ISO 13485, FDA Quality System Regulation (21 CFR Part 820));
• Experience in conducting validation for in-house and third-party tools;
• Experience in preparation / review of product-specific lifecycle documentation intended to confirm quality of the product;
• Good understanding of Risk Management principles and technics (Failure Mode and Effect Analysis (FMEA), FTA and other);
• Good understanding of medical device SQA principles and related regulations: ISO 13485, IEC 62304, ISO 14971, FDA QSR Part 820, EU MDR;
• Good understanding of software V&V methodologies and software development life cycle;
• Good understanding of software testing principles;
• Ability to work with big amounts of information, produce and organize content in a logical flow;
• Strong documentation management skills, ability to review, analyze and interpret complex and complicated documents;
• Good analytical skills;
• Attention to details and being a kind of a perfectionist;
• Ability to cope with quite routine work;
• Team player;
  
  
  

English:

• Upper Intermediate or higher; ability to communicate with native speakers is a must;
  
  
  

Would be a plus:

• Deep knowledge of medical-specific standards / government regulations;
• Experience in creating and verifying of IT project or QMS technical documentation (software requirements / design specifications, project plans and reports, work procedures);
• Experience to work effectively cross-functionally with developer/test audience;
• Technical background;
• Education: bachelor’s degree or higher in Engineering / metrology / quality / certification
  
  
  

Job responsibilities

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;

Assessing project activities and deliverables against established procedures, standards and regulations (QMS for medical device software development)

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

What we offer

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.

About GlobalLogic

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.