Product Quality Manager
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3Shape is the leading global 3D scanner system provider of state-of-the art digital products for the dental industry. We are currently looking for a Product Quality Manager to strengthen the Quality Assurance in the Scanner Development Department. This includes projects from the handheld scanning hardware to application software. Together with the Systems and Architecture Manager and in collaboration with the individual projects, you will take our Product Quality Assurance to the next level.
You will refer to the Systems and Architecture Manager.
The position
As our new Product Quality Manager, you will work closely together with R&D stakeholders, quality stakeholders, and regulatory stakeholders on our Intra-oral scanner systems.
The main tasks involve:
Quality Assurance and Design Control
- Lead quality assurance and support Design Control for our IOS.
- Be a strong player in conducting reviews.
CAPA and Non-Conformities
- Actively engage in supporting the completion of CAPA’s with our quality and RD organization.
- Be on top of potential non-conformities and support completion of non-conformities.
Support projects as part of a cross-functional team
- Quality Assurance and Design Control to obtain better overall Quality in our deliverables.
- Support Risk Management and Requirement Management in our tool, Jama.
- Support best practice in verification and validation.
Your profile
The successful candidate must have a strong quality profile and understand multiple technological areas and how they interact in a system. We are looking for some who have a strong quality and technical background (Master of Science, or similar, with good merits), and preferably 3 years of experience from working with Medical Devices. Moreover, we expect that:
- You are radiantly passionate about quality and have a strong drive to improve our approach to Quality Assurance.
- Knowledge and hands-on experience with ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, MDR, and 21 CFR.
- Experience from working with Document Management Systems.
- Audit experience (external and internal).
We are looking for a person who:
- Maintain a methodical approach to your work.
- Have an eye for value-related detail and appreciate good documentation.
- Are a team player and an outgoing and a strong communicator (written and oral English).
- Through your work, you will influence the successful outcome of a strategically important market for 3Shape, which closely aligns with our mission of providing superior patient care.
- Will also help to lift our team to a new level, in a sometimes chaotic and fast-paced workday, while still having fun!
In our search for new colleagues, we always look for people with a cross-disciplinary and an open mindset. Through cooperation with project managers, developers, product managers, production engineers, supporters and service personnel, you will get an in depth understanding of all aspects of 3D scanner development, and use this to enable our further growth and success.
We offer
- An opportunity to become part of the success that 3Shape has created over the past 20 years.
- Empowerment and challenging tasks in a young and successful MedTech company.
- Nice work-life balance.
- An opportunity to improve the comfort and treatment of dental patients by developing the technology of tomorrow.
- An attractive work environment with an informal atmosphere in downtown Copenhagen, among best-in-class colleagues.
Working for 3Shape also means an attractive work location in downtown Copenhagen, fresh lunch cooked by our resident chefs in our new canteen, an international atmosphere, and competitive packages to keep you feeling valued.
Learn more about 3Shape and our recruitment and onboarding process on our web page: 3Shape.com and take a look at our Facebook-page "Lifeat3Shape” to find out why 3Shape is a great place to work. We look forward to receiving your application through our recruitment system.
Get in touch now!
If you are interested in this exciting opportunity, apply already today. We will review the applications continuously.
We encourage all relevant applicants to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status. All qualified applicants will be given equal opportunity and the selection is based on job-related factors.
About us
3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,600+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on Facebook.
Information og data
Denne ledige stilling har jobtypen "Kvalitetskoordinator", og befinder sig i kategorien "Kontor, handel og service".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 12.3.2021, men kan have været deaktiveret og genaktiveret igen.
- Kvalitetskoordinator
- København
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