Quality Assurance Specialist - Medical Software

Festanstellung, Vollzeit · Software Team

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 tasks

Medical Software Quality Assurance
- Conduct 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 support
- Support 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 profile

Bachelor’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 Qualification
- Certification in quality management (e.g., CQE, CQA)
- Experience with FDA and MDR regulatory submissions

Our offer

Competitive 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

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About us

Your Career at NIHON KOHDEN

Become part of the Nihon Kohden community! Nihon Kohden has a unique Japanese culture in a European setting and we are happy to add you to our family. We are looking for people who show initiative in their job and enjoy working in an international team. Bring your competence, personality and expertise to us.

If you decide to apply for one of our open positions, we ask you to send us your application by using the application link included in every job advertisement. After we have reviewed your application and it has convinced us, we will invite you to get to know us personally. Typically, there will be two rounds of interviews, and the first round interview is set up as a video conference call.

If the first interview went well and we have the impression that you might be a good fit for our open position, we will sit down with you for a second interview. This will take place as a personal meeting. Here you will meet colleagues, contact persons and other managers. It gives you the chance to get a feeling for our company, the department and your potential future colleagues.

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Wir freuen uns auf Ihre Bewerbung!

Wir freuen uns über Ihr Interesse an einer Mitarbeit bei Nihon Kohden. Bitte befüllen Sie die jeweiligen Angabefelder mit Ihren Angaben. Sollten Sie Schwierigkeiten mit dem Upload Ihrer Daten haben, wende Sie sich gerne per Email an application@nke.de.