QA Analyst (Denmark) (offline)
Requirements:
Experience in quality assurance, 3-5 years
Strong understanding of medical device design assurance
Experience in management of QA professional and technical staff
Expertise in standards and regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, EU MDR, etc) affecting medical devices marketed in all regions throughout the world
Specific experience in MDR.
Working knowledge in risk management file of medical devices, complaint analysis, standards (like IEC 60601-1) gap analysis, knowledge on medical device labels like product labels, IFU, service manual, etc.
experience on EU MDR, CE marking documentation
We offer:
Highly creative and dynamic environment, what offers healthy professional challenge to professionals.
Long-term projects and cosy atmosphere.
Competitive salary
Paid accommodation
About ITSM Delivery
Adaptive sourcing of IT competencies and resources:- Outstaffins solutions
- It outsourcing brokerage
- Supplying IT professionals for projects:
- terminated contracts,
- from junior to senior levels
Translation services.
IT consualtions and trainings.
Project management consulations and trainings.
Company website:
http://www.itsmdelivery.com
DOU company page:
https://jobs.dou.ua/companies/itsm-delivery/
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