職種概要
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.
必要条件
Job Description:
- At least 2-5 years of proven 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;
- Deep understanding and extensive practical application of relevant medical device standards and regulations: ISO 13485, IEC 62304, ISO 14971, FDA Quality System Regulation (21 CFR Part 820), and preferably EU MDR/IVDR requirements for software.
- Strong knowledge, deep understanding and practical application (implementation, support) of international quality management system standards and regulations (e.g. ISO 9001:2015, ISO 13485, FDA Quality System Regulation (21 CFR Part 820));
- 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));
- Good understanding of Risk Management principles and technics (Hazard Analysis, Failure Mode and Effect Analysis (FMEA), FTA and other);
- Good understanding of SDLC models (Agile, Waterfall, Hybrid), Configuration Management principles, Change Control processes, Traceability tools/techniques.
- Good understanding of software testing principles, V&V methodologies and strategies;
- Experience in preparation / review of product-specific lifecycle documentation intended to confirm quality of the product;
- Ability to review, analyze and interpret complex and complicated documents;
- Ability to work with big amounts of information, produce and organize content in a logical flow;
- Ability to understands and subsequently explain complex quality details to non-experts and coach the team;
- Excellent written and verbal communication skills;
- Good problem-solving 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;
#LI-2KK #LI-Remote
職務内容
- Support execution of Quality and design-control activities for software and firmware development projects, including requirements, design reviews, traceability, verification/validation, change assessment, and software release documentation.
- Lead/execute risk-management activities, including design FMEAs, identification of failure modes, hazardous situations, risk controls, and evaluation of software defects and unresolved anomalies.
- Provide IEC 62304 software lifecycle expertise and help development teams appropriately apply software lifecycle requirements. Identify gaps or ambiguity within Midmark’s existing software development processes.
- Drive software reliability and robustness by partnering with development and test teams to identify potential failure conditions, challenge design assumptions, ensure appropriate testing of abnormal, boundary, fault, and recovery conditions, ensure robust quality processes and regulatory compliance.
- Participate in Continuous Value Delivery (CVD) quarterly planning to provide Quality and risk-based input into prioritization of software defects, enhancements, and development projects.
- Communicating with a customer on quality assurance, process management, documentation preparation topics.
This role is critical for ensuring patient safety, product effectiveness, and successful regulatory submissions.
私たちが提供するもの
Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. As a team, we engineer digital products that positively impact people’s lives.
Empowering Growth: We foster a culture of continuous learning and professional development. Our dedication is to provide timely and comprehensive assistance for every consultant through our dedicated Learning & Development team, ensuring their continuous growth and success.
DE&I Matters: At GlobalLogic, we deeply value and embrace diversity. We are dedicated to providing equal opportunities for all individuals, fostering an inclusive and empowering work environment.
Career Development: Our corporate culture places a strong emphasis on career development, offering abundant opportunities for growth. Regular interactions with our teams ensure their engagement, motivation, and recognition. We empower our team members to pursue their career goals with confidence and enthusiasm.
Comprehensive Benefits: In addition to equitable compensation, we provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. We genuinely care about their health and strive to create a positive work environment.
Flexible Opportunities: At GlobalLogic, we prioritize work-life balance by offering flexible opportunities tailored to your lifestyle. Explore relocation and rotation options for diverse cultural and professional experiences in different countries with our company.
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.
