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Quality Engineer

About Usono 

Usono is a MedTech company that revolutionizes musculoskeletal (MSK) ultrasound through dynamic imaging solutions. Our main product, ProbeFix Dynamic, is used by doctors of elite sports organizations such as Red Bull Salzburg, AS Roma, hospitals like Radboud UMC and Amsterdam UMC and research institutions such as MIT. Thanks to our hardware, they unlock new insights in the body in movement, for prevention, diagnosis and rehabilitation. 

We are seeking a hands-on and experienced quality and regulatory engineer to enhance and manage our quality system and ensure regulatory compliance. Usono has a ISO13485-compliant quality management system and a CE-marked product (ProbeFix Dynamic). Multiple products are under development, including a software proposition.  

In this role (3-4 days/week) you will be responsible for developing and implementing the quality management system, including training of personnel. You will monitor and ensure compliance with the relevant regulations and standards.  

The Job 

As our Quality Engineer, you will work closely with the CTO to enhance and manage our quality management system and ensure regulatory compliance. You’ll shape the future of dynamic ultrasound by: 

• Defining, implementing, and maintaining procedures for medical device quality and regulatory assurance (ISO 13485, MDR and FDA).  
• Developing, reviewing, and approving technical documentation, including test protocols, validation reports, work instructions, and design control documents, ensuring accuracy and traceability. 
• Planning and conducting internal audits, supporting external audits and ensuring timely and effective closure of all audit findings and non-conformities. 
• Creating training materials and templates and training the team members. 
• Taking the lead in managing, documenting, and reporting quality aspects to the management team 
• Improving our supplier and customer management processes. 
• Implement quality control activities for the R&D team. 
• Be involved in all aspects of the quality management system, like post-market surveillance, risk management and CAPA management.  

Who You Are 

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum of 5 years of experience in a Quality Assurance or Quality Engineering role within the medical device industry.
• Deep working knowledge and practical experience with medical device regulations and standards (EU MDR, ISO 13485, FDA QSR 21 CFR Part 820, ISO 14971).
• Strong analytical, problem-solving, and critical thinking skills (e.g., root cause analysis, statistical techniques).
• Experience with hardware (no electronics) and software as a medical device.
• You have a strong personality, and you can drive quality initiatives while remaining collaborative, listening actively, and working effectively within teams.
• Not afraid to take responsibility and own deliverables.
• Excellent written and verbal communication skills, with the ability to work effectively in teams and interact with regulatory agencies.
• English is must, Dutch is a big plus.

What We Offer 

• A key role in a fast-growing and internationally operating company.
• Hybrid working, partially on High Tech Campus Eindhoven, partially from home.
• Flexible working days and hours (3-4 days a week).
• Potential to participate in equity through SARs (details to be communicated in later interview stage).
• A chance to shape the future of medical ultrasound in elite sports and rehabilitation.

Ready to Make an Impact? 

If you’re passionate about innovation in medical technology and want to help shape the future of dynamic ultrasound, we’d love to hear from you, so apply  📩! If possible, add any relevant work or portfolio you might have.