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Quality Assurance Expert
2 months ago
About the role
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
Your profile
- 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
Why 3Shape?
- An attractive healthcare package to keep you fit and well
- Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
- Good work/life balance e.g., work from home policy for up to 2 days per week
- Amazing location – our office is located in the heart of Copenhagen, right next to Kongens Nytorv
- A joint purpose: to enable dentists to provide superior patient care to every patient, every time