AboutUsono
Usonois 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 likeRadboudUMCand AmsterdamUMCand research institutions such as MIT.Thanks to our hardware, they unlock new insights in the body in movement, for prevention,diagnosisand rehabilitation.
We areseekinga hands-on and experiencedquality andregulatoryengineerto enhance and manage our quality system and ensure regulatory compliance.Usonohasa ISO13485-compliant quality management system and a CE-marked product (ProbeFix Dynamic).Multiple products are under development, includingasoftwareproposition.
In thisrole(3-4 days/week) you willbe responsible fordeveloping and implementing the quality management system, includingtraining ofpersonnel.You willmonitorand ensure compliance with the relevant regulations and standards.
The Job
As ourQuality Engineer, you will work closely with the CTO toenhance and manage our quality management systemand ensure regulatory compliance.You’llshape the future of dynamic ultrasound by:
* Defining,implementing, andmaintainingprocedures for medical device qualityand regulatoryassurance (ISO 13485,MDRand FDA).
* Developing, reviewing, and approvingtechnical documentation, including test protocols, validation reports, work instructions, and design control documents, ensuring accuracy and traceability.
* Planningand conductinginternal audits, supportingexternalauditsandensuringtimelyand effective closure of all audit findings and non-conformities.
* Creatingtrainingmaterialsandtemplates andtrainingthe team members.
* Takingthe lead in managing, documenting, and reporting quality aspectsto themanagement team
* Improvingour supplier and customer management processes.
* Implement quality control activitiesfor the R&D team.
* Be involved in all aspects of the quality management system,likepost-market surveillance, riskmanagementand 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 CampusEindhoven, partially from home.
* Flexible working days and hours (3-4 days a week).
* Potential toparticipatein 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?
Ifyou’repassionate about innovation in medical technology and want to help shape the future of dynamic ultrasound,we’dlove to hear from you, so apply below 📩! If possible, add any relevant work or portfolio you might have.
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