Vacant job

At Knightec, we understand that improving the quality of life for patients by ensuring medical devices and pharmaceuticals is of utmost importance. We also work to secure requirements and quality for food based on our expertise in compliance. By balancing quality and regulatory compliance during the product and production development process, you play a crucial role in introducing new technology and more efficient medical equipment, pharmaceuticals, and food to the market.

Why this job is for you:

• You want to improve the quality of life for patients through safe medical devices and pharmaceuticals

• You strive to find the right balance between quality and regulatory compliance during the product development process

• You aim 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 technology and more effective medical equipment to the market

• You want to use your full expertise in various 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 on significant responsibility in your assignments

• You value working in an environment characterized by trust, transparency, and collaboration

Your experiences:

Your key qualities are your willingness to learn and share your knowledge with others. As our ambition is to help our clients take the next step into the future through digital tools, we see that you have an interest in new technology and digitalization. It is particularly interesting if you have experience or interest in working with software quality assurance or connected devices.

You also have:

• Engineering degree in biotechnology, medical technology, chemical engineering, or similar

• Experience working with product development quality within the medical technology industry, such as Design Control, CE marking, Quality Assurance, Regulatory Affairs, or quality management systems

• Experience working in a regulated production environment, e.g., within pharmaceuticals.

• Good knowledge of relevant regulatory requirements and standards such as MDD/MDR, ISO 13485, ISO 14971, IEC 62304, and GMP

• Excellent communication skills in Swedish and English

Build a career to be proud of:

Your development is important to us. No matter where you see yourself in the future, we are here to support you. Your ambition and willingness guide the direction, while we provide you with the tools and conditions to succeed. Through mentorship, knowledge-sharing forums, knowledge exchange, and a team-oriented approach, you will be able to benefit from the collective expertise within Knightec, which acts as a catalyst for your own development.

You will be part of our national initiative within Medtech Compliance, where you will have access to training and certifications and work with some of the industry's most prominent players. If you value your professional development, we will do the same.

An exciting journey with Knightec Group

We at Knightec (https://knightec.se/) are now joining forces with our sister company Semcon (https://www.semcon.com/sv) to form Knightec Group. Together, we will become the leading player in Northern Europe in product and digital service development – how exciting is that? Our joint offering will be both broader and deeper, allowing us to take on large, strategic customer projects at the highest level of innovation and complexity. For our employees, this means fantastic opportunities for skill development and career paths. Does this sound like the place for you? Join us on this exciting journey!