Junior/Middle Software Quality Assurance Analyst IRC259454

Description

Inviting a Software Quality Assurance Analyst to join a growing account in the medical devices industry domain. Our client is the global leader company of healthcare solutions, which contributes to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health and extend life for people around the world.

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