About this role
Why This Job is for You At Knightec Group, we understand that improving patient quality of life by ensuring medical technology products and pharmaceuticals is of utmost importance. By balancing quality and regulatory compliance throughout product and production development processes, you will play a crucial role in introducing new technologies and more efficient medical equipment and drugs to the market. Your development is important to us. Your ambition and willingness guide the direction, while we provide you with the tools and conditions to succeed. Through mentorship, competence-sharing forums, knowledge exchange, and a team-oriented approach, you will be able to access the collective expertise within Knightec Group. You will become part of our national Medtech Compliance initiative, where you will participate in training and certifications. Within our Compliance & Management business area, we support an effective transition to digital, sustainable, and secure solutions through expert knowledge in areas such as quality, safety, sustainability, and project management.
Responsibilities In this role, you will work on varied and developmental assignments for companies of different characteristics where your expertise is needed.
• You will improve patient quality of life through safe medical technology products and pharmaceuticals
• You will strive to find the right balance between quality and regulatory compliance during product development processes
• You will strive to find the right balance between quality and regulatory compliance in a highly regulated production environment such as GMP
• You want to be an important part of introducing new technologies and more efficient medical equipment to the market
• You want to use your full competence in varied projects, from start-ups to well-established international companies
• You have expertise in Design Control, technical documentation, Quality Assurance, or regulatory requirements and want to take significant responsibility in your assignments
• You value working in an environment characterized by trust, transparency, and collaboration
Qualifications Your most important qualities are your willingness to learn and share your knowledge with others. Since our ambition is to help our customers take the next step into the future through digital tools, we see that you have an interest in new technology and digitalization. It is especially interesting if you have experience or interest in working with software quality assurance or connected equipment.
You also have:
• Engineering degree in biotechnology, medical technology, chemical engineering, or similar
• Experience working with product development quality in the medical technology industry, such as Design Control, CE marking, Quality Assurance, Regulatory Affairs, or quality management systems
• Experience working in regulated production environments, such as pharmaceuticals
• Good knowledge of relevant regulatory requirements and standards like MDD/MDR, ISO 13485, ISO 14971, IEC 62304, and GMP
• Fluent knowledge of Swedish and English
An Exciting Journey with Knightec Group Semcon and Knightec have merged as Knightec Group. Together, we form Northern Europe's leading strategic partner in product and digital service development – how amazing is that?
With a unique combination of cross-functional expertise and a holistic understanding of business, we help our customers realize their strategies – from idea to finished solution. At Knightec Group, we have the competence, attitude, and drive required to take on the most challenging and innovative projects.
For our employees, this means fantastic opportunities to help shape the future through meaningful projects at the absolute forefront of technology. Here, you not only develop and grow but also become part of something larger.
Does this sound like the place for you? Join us on an exciting journey!
Practical Information This is a permanent employment with a six-month probationary period, located at our office in Malmö, Ångbåtsbron 1, or our office in Helsingborg, Stortorget 11. Business travel to our customers may occur. Start date is as soon as possible or by agreement.
Submit your application as soon as possible, but no later than 2025-12-07. If you have any questions about the position, please contact Talent Acquisition Partner Lina Orfanidou. Please note that due to GDPR, we only accept applications through our career page.
We look forward to hearing from you!