Software Quality Assurance Analyst (IRC288813) $$

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. 

Job Description

• At least 2-5 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 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