Vacant job

Do you want to work with product development and play a key role in ensuring that medical technology products are developed, verified, and documented according to current regulatory requirements? We are looking for an experienced Quality Engineer with strong competence in design control and technical documentation. This role combines quality and product development and spans the entire product lifecycle. This is a role for you who have a deep understanding of medical technology development and are accustomed to working systematically with complex documentation and requirement-driven processes.

About the role

As a Quality Engineer, you work with design control throughout the product's lifecycle, contributing to requirements, risk, verification, and other work related to technical documentation and product development. Among other things, you will:

• Drive and support design control work throughout the product lifecycle
• Ensure requirements management and traceability between requirements, design, and verification
• Work with risk management related to the product and its use
• Participate in the creation and review of technical documentation
• Ensure that products meet regulatory requirements within MDR and ISO 13485
• Contribute to work on biocompatibility and usability engineering
• Support the development and management of requirement specifications
• Participate in lifecycle management and change control
• Collaborate cross-functionally with development, quality, and external partners

Your background

We are looking for you who have experience from medical technology product development or quality assurance and who are confident in working with complex, regulation-driven processes. It is not crucial that you have a background in specific technology (mechanics, electronics, or software), but it is an advantage if you have worked closely with technical development teams. You have:

• An academic degree in biomedical engineering, mechanical engineering, biotechnology, or equivalent
• At least 5 years of experience working in medical technology in roles such as Quality Engineer, Product Developer, or similar
• Very good understanding of design control
• Experience with risk management
• Experience working with technical documentation and requirement-driven processes
• Good knowledge of MDR and ISO 13485
• Good skills in Swedish and English

Personal qualities

As a consultant, you thrive in new environments and find it easy to build trusting relationships, both with colleagues and clients. You take responsibility for your work, are curious, and have the ability to see the big picture. To succeed in the role, we see that you are analytical and structured and enjoy creating order in complex information.

Together Tech for sustainable product development At Together Tech, you have the opportunity to contribute to the development of advanced medical technology products at some of the industry's most exciting companies. Through our client assignments, you will work closely with technology, quality, and innovation while developing alongside engaged colleagues.

Your development & our support🌱 We care about both your development and well-being and offer among other things:

• Secure employment with collective agreement
• Health allowance of 4,000 SEK per year plus discounts on fitness activities
• Social team activities – from afterworks to sports activities
• Individual development plans and opportunities for courses in areas such as sustainability
• A company that for three years in a row, 2024, 2025 & 2026, has been named one of Sweden's most attractive employers by Karriärföretagen 🌟

If you want to know more about us, please visit our website www.togethertech.com (http://www.togethertech.com)

For questions regarding the position, please contact Consultant Manager Sofia Nilsson via email or phone at 0737-17 94 38.