Quality Engineer - Software as a Medical Device

ALTEN SWEDEN IS CURRENTLY SEEKING A HIGHLY SKILLED AND MOTIVATED QUALITY ENGINEER SPECIALIZING IN SOFTWARE AS A MEDICAL DEVICE (SAMD). THIS IS AN EXCITING OPPORTUNITY TO JOIN OUR DEDICATED TEAM, WORKING ON INNOVATIVE PROJECTS WITHIN THE MEDICAL DEVICE INDUSTRY. AS A QUALITY ENGINEER AT ALTEN SWEDEN, YOU WILL PLAY A VITAL ROLE IN ENSURING THE SAFETY, RELIABILITY, AND COMPLIANCE OF MEDICAL DEVICE SOFTWARE.

Responsibilities:
Collaborate with cross-functional teams to develop and implement effective quality management systems for software as a medical device.
Contribute to the creation and maintenance of software development and validation processes, ensuring compliance with relevant standards and regulations (e.g., ISO 13485, IEC 62304, IEC 82304).
Perform risk management activities, including risk assessment, risk mitigation planning, and documentation according to ISO 14971.
Participate in design reviews, ensuring software requirements are properly defined and traceable.
Conduct audits and inspections to ensure compliance with quality standards and regulatory requirements.
Stay up-to-date with the latest industry trends and regulatory changes in software as a medical device.

WHAT WE OFFER YOU

At ALTEN, every individual is equally valuable in building tomorrow’s world today. We meet future challenges by supporting our clients’ projects and enabling our people to reach their full potential. We do so by offering technological challenges, fulfilling opportunities, inspiring togetherness and the possibility to contribute to a sustainable future.

We are convinced that your development is driven by your passion. By being active in several different industries, we can offer a wide range of assignments and an opportunity to influence both the world around you and your own development.  With a coaching leadership, our leaders will guide you in the right direction. We also offer personalized training opportunities through your individual training budget, which you can use in our internal ALTEN Academy or on external courses.

At ALTEN, we think it's important to have a balance between work and spare time, which is why we offer three extra days off a year. We have a collective agreement and offer benefits like pension, insurances and wellness grants.


REQUIREMENTS:
Bachelor's or Master's degree in Engineering, Computer Science, or a related field.
Minimum 3 years of work experience with quality management systems and regulations, such as ISO 13485, IEC 62304, IEC 82304, and other relevant standards.
Experience from Medical Device Development

 You should also be fluent in English, both written and spoken.

The recruitment process is ongoing - apply today! 

If you have any questions, please contact Talent Acquisition Partner Märta Hägg Wass at marta.haggwass@alten.se.

ABOUT ALTEN

ALTEN is one of Europe’s largest consulting companies within Engineering, IT and Life Sciences with over 54,000 employees in more than 30 countries. We’re a global actor with a local presence with 1400 committed colleagues in offices from Lund in the south to Skellefteå in the north. Our engineers carry out complex and highly technical projects throughout the product development chain of the most prestigious companies in sectors such as Automotive, Aerospace & Defense, Energy, Manufacturing, Public Sector and Life Sciences.

For four years in a row, ALTEN has been named one of Sweden's most attractive employers by Karriärföretagen, an award for employers that offer unique career and development opportunities.