Description:
Our client is one of the largest manufacturers of medical devices and software in the United States. One of their products is a small device designed for people suffering from diabetes, which is attached to the body in order to measure and regulate the necessary level of glucose in the blood by injecting the appropriate dose of insulin. This device enables patients to lead a comfortable lifestyle without worrying about their health, as it was before.
Requirements:
- At least 1-3 years of IT industry experience (QA 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;
- Strong knowledge and a good understanding of international quality management system standards (e.g. ISO 9001:2015);
- Experience in implementation, supporting and auditing/assessment of Quality Management System;
- Good understanding of Risk Management principles and technics (Failure Mode and Effect Analysis (FMEA) and other);
- Knowledge of software development life cycle and process of quality control;
- 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 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:
- Understanding 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 in work with developer/test audience;
- Technical background;
- Education: metrology, quality, certification would be a huge plus
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
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.
About GlobalLogic GlobalLogic is a leader in digital engineering. We help brands across the globe design and build innovative products, platforms, and digital experiences for the modern world. By integrating experience design, complex engineering, and data expertise—we help our clients imagine what’s possible, and accelerate their transition into tomorrow’s digital businesses. Headquartered in Silicon Valley, GlobalLogic operates design studios and engineering centers around the world, extending our deep expertise to customers in the automotive, communications, financial services, healthcare and life sciences, manufacturing, media and entertainment, semiconductor, and technology industries. GlobalLogic is a Hitachi Group Company operating under Hitachi, Ltd. (TSE: 6501) which contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business.
