Vacant job

Why this job is right for you

You want to work within quality and validation where you truly get to make a difference in people's daily lives. We develop medical technology products that make it easier to feel better. Technology that is easy to use, safe, and connected for the best possible experience.

You will become part of a happy and competent team where good collaboration, exciting assignments, knowledge sharing, and social activities are a natural part of the work. Here, you and your development are in focus. You will have a continuous dialogue with your manager regarding future development opportunities to shape a plan that suits you and your ambitions.

Within our business area Compliance & Management, we support an efficient transition to digital, sustainable, and secure solutions through expert knowledge in areas such as quality, safety, sustainability, and project management.

Responsibilities

The role involves leading and executing equipment and system qualification, as well as developing and reviewing quality and regulatory documents within medical technology, though it may also cover pharmaceuticals and food. Depending on the assignment, you will work with:

• Process validation
• GAP analyses
• Classification and release of medical devices
• MDD/MDR
• ISO 13485
• Design control
• 21 CFR 820
• QMS (Quality Management Systems)

Qualifications

We are looking for someone who is quality-conscious and thrives in a varied role. You enjoy sharing knowledge and working with various stakeholders. Additionally, we require experience in one or more of the following areas:

• Product or process validation
• Non-conformance management
• Traceability systems
• ISO 13485

Furthermore:

• Degree in medical technology, chemical engineering, biotechnology, or equivalent
• Fluent proficiency in Swedish and English, both written and spoken

An exciting journey with Knightec Group

Semcon and Knightec have joined forces as Knightec Group. Together, we form Northern Europe's leading strategic partner in product and digital service development – how cool 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 possess the competence, attitude, and drive required to take on the most challenging and innovative projects.

For our employees, this means fantastic opportunities to shape the future through meaningful projects at the absolute forefront of technology. Here, you will not only develop and grow but also become part of something bigger.

Does this sound like the place for you? Join us on an exciting journey!

Practical Information

This is a permanent position with a six-month probationary period, located at our office in Gothenburg, Lindholmsallén 2. Business travel to our customers may occur. Start date is by agreement.

Please submit your application as soon as possible, but no later than 2026-08-10. If you have any questions about the position, you are welcome to contact Oliver Rydberg, Talent Acquisition Specialist.

Please note that due to GDPR, we only accept applications via our career page.

We look forward to hearing from you!