Quality Assurance Specialist - Medical Software Sesto San Giovanni

Quality Assurance Specialist - Medical Software
Sesto San Giovanni
Lombardia, Sesto San Giovanni

Why us? Software Team is a small-sized software house based in Milan, Italy, part of the Nihon Kohden Corporation, one of the leading global companies in the field of medical devices, based in Japan.

Software Team is the Nihon Kohden research and development department for Europe, focused on design, production, and maintenance of Software as Medical Device. The company also provides after sales technical support. Our goal is to improve healthcare with advanced technology.

For more than 70 years, Nihon Kohden has offered a wide range of medical electronic devices.

SmartLink, the most important product of Software Team, is a Distributed Clinical Alarms Management, with installations in hospitals all over Europe.

For our team in Milan, Italy we are looking for a Quality Assurance Specialist.

Your tasksMedical Software Quality AssuranceConduct thorough hazard analyses and risk assessments for medical software. Identify potential hazards and evaluate associated risks; develop and implement risk mitigation strategies. Ensure compliance with risk management standards (e. g. , ISO 14971) and document and maintain risk management files. Conduct software testing, validation, and verification and execute software quality assurance plans. Quality System Management supportSupport the maintenance and improvement of the ISO 13485 quality management system. Assist in internal and external audits. Assist in the preparation of regulatory submissions and documentation and ensure products comply with regulatory standards and guidelines (e. g. , FDA, MDR). Provide training and support to staff on quality assurance practices and regulatory requirements. Your profileBachelor's degree in engineering, Computer Science, or a related field. Experience in medical software quality assurance or engineering. Experience with ISO 13485 quality systems. Basic understanding of regulatory requirements for medical devices. Strong problem-solving and analytical skills. Excellent communication and interpersonal skills. Ability to work independently and collaboratively. Preferred QualificationCertification in quality management (e. g. , CQE, CQA). Experience with FDA and MDR regulatory submissions. Our offerCompetitive salary and benefits package. Opportunity to work on innovative projects that make a real difference. Supportive and collaborative work environment. Professional development and growth opportunities. Company details

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