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Software Quality Assurance Engineer

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Contratto a tempo indeterminato
    Multinational Public Listed Company that delivers design, engineering, manufacturing, real-time supply chain insight and logistics services to companies in the Healthcare Market As a Software Quality Assurance Engineer you will work with the design team members and you will be responsible for moderately-complex system and board level design in order to meet customer's requirements from development of conceptual prototypes and architecture through development into full-scale production. Specifically you will: Guide design team in conformance to the international standard applicable to the SW Development process (i.e. ISO 13485, IEC 62304). Serve as lead and coach in the implementation of design control and SW risk management requirements per above standards. Work within the design team to ensure that standard operating procedures are correctly used and maintained during the product development. Ensure that project data and documents related to SW development process are managed according to document and change control procedure. Act as administrator of the SW Configuration Management System Record and fill in relevant documents for SW QA. Supporting customers in SW quality assurance activities. Participates in ISO Certification and surveillance audits and customer audits Graduate in Computer Science, Electronic Engineer, SW Engineering or equivalent combination of education and experience A minimum of 2 years of SW QA experience. Broad theoretical understanding and practical knowledge of SW Quality Assurance processes/techniques in Product Development Process. SCM (SW configuration management) tools such as Clearcase, Subversion, Bugzilla, etc. Build management. Knowledge of IEC62304, SW FDA guidelines is required. The knowledge of ISO 13485, 21 CFR part 820, AAMI TIR32:2004; ISO14971; IEC/TR 80002-1 is recommended. Must have ability to manage multiple products QA activities and multiple customers concurrently. Must have good organizational, time management, team building, verbal and written communication skills. Fluency in spoken and written English
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