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Quality Management System Specialist
1 month ago
Position: Quality Management System Specialist
Application closes at: Feb 16th, 2025 23:00
With the X1 CBCT unit, we brought exciting and radical innovations to the field of dental radiology. To deploy the product globally, we are currently restructuring our organization and look for talent to support this process.
Born out of the most successful Danish start-up company in recent years, we are a small team dedicated to bringing the X1 CBCT unit to the commercial position it rightfully deserves. We aim to expand our team significantly over the next years. Most importantly, we are locked into the mission of bringing CBCT scanning to the next level by enabling true motion correction and high fidelity scanning to clinics across the world.
Innovation is in our DNA. We are energized by making a positive 'human' impact in the work we do. Teamwork is king, and we pride ourselves on providing an opportunity for the industry's best talent to spar, collaborate and learn from each other along the way. We know that we don't know everything, but we are fast learners.
The Job
You will be responsible for our Quality Management System, ensuring that our products are compliant with regulations, standards, and directives of the markets. This includes planning and participating in audits, following up on non-conformities, coordinating QMS reviews (including management reviews), and generally ensuring that we work according to our process descriptions.
Our goal is to be compliant by default, meaning that our QMS should be easy to work with, and not require burdensome and repetitive tasks for no reason. Hence, we expect that you can drive the relevant improvements of the QMS and help us focus on what is important.
Lastly, you will help ensure that our product releases are fully documented and that our technical documentation is complete and ready for submission when agreed upon.
As we are a small team, you should expect tasks that are not listed above – and be ready to step in where needed.
Your Profile
The ideal candidate will possess most of the following qualifications:
- M.Sc. degree or higher, preferably within biomedical or electrical engineering
- Experience working with QA/QC for medical devices
- Experience with mixed technology products
Documented expertise in the main standards governing medical device development and production, such as MDR, ISO 13485, ISO 14971, IEC 62304, and IEC 60601.
Excellent communication and documentation skills -- English at business level, and generally comfortable in an international atmosphere.
Excellent at creating and maintaining cross-functional working relationships.
Most importantly, you are passionate about providing high-quality and innovative solutions and enthusiastic about the possibility of working with skilled colleagues to influence the future of dental imaging.
To put it simply, we will prioritize energy, can-do attitude, and motivation over the number of years you have been in business.
We offer
- Professional challenges in a small, highly dynamic, and globally oriented business environment.
- Experienced and skilled colleagues
- The chance to influence the next generation of 3D Dental X-ray scanner solutions, and the future of a startup company.
- Open, honest, and constructive work environment.
- Compensation package matching your skills and commitment
