Software Quality Assurance Analyst Offline
Description
Healthcare/Medical Device Software Development
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
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