Quality Assurance Specialist
4 weeks ago
We are seeking a Quality Assurance Specialist to contribute to developing scanner systems, a combination of hardware and software systems in the medical device domain. You will work on improving the quality aspect in our development projects as part of a cross-functional team.
Your Responsibilities- Lead quality assurance in a development project
- Contribute to Design Control for our Intra Oral Systems
- Conducting reviews and support risk management
- Guidance during root cause analysis
- Support the completion of CAPA's with our Quality and RD organization
- Support, review, and improve the Technical File documentation process
- Knowledge of quality assurance in a product development context
- Experience with design control, CAPA, change control, and non-conformities
- Knowledge and hands-on experience in ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, MDR, and 21 CFR Part 820, GDP, GMP
- Ability to address complex matters and take tough decisions
- You like working in teams and have a hands-on approach
- Experience from working with Document Management Systems and audits (external and internal) is beneficial
3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ 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 LinkedIn.
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Quality Assurance Specialist
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