We are looking for a:
Head of Quality
ready to join our team in expanding our business in the medical devices area.
Place of work: Belgrade
Responsibilities:
- Quality assurance and regulatory requirements for medical devices
- Managing QMS compliance to the requirements of ISO 13485, MDD, FDA 21CFR 820, ISO 9001, ISO 14001, OHSAS 18001, ISO 27001
- Leading regulatory/QMS audits
- Maintain CAPA system
- Management review
- Managing product registrations and renewals
- Preparing documentation for finished products release
Required skills:
- Bachelor Degree or above in Engineering or Science
- 3 years’ experience in quality and regulatory area (experience in medical device industry is an advantage)
- Knowledge of Quality Management regulations ISO 13485, MDD, 21 CFR 820 and audit experience (Certificate is an advantage)
- Knowledge of medical device regulation in Republic of Serbia, EU and USA
- Strong initiative, problem solving and investigative ability, attention to detail and drive
- Capacity to lead a team effectively and work independently
- Proficiency in English (German or other language is an advantage)
We are offering:
- An interesting job in a dynamic and ambitious company producing advanced technologies in medical diagnostics
- Possibility of advancement and international experience
- Attractive package based on contribution
Send your and CV and application electronically.
Deadline for applications: 03.05.2018.
Visaris d.o.o., Beograd
Visaris is a privately owned company, founded in 2003, that has established itself as a regional leader in the field of digital x-ray imaging and diagnostic workflow. Our vision is to offer our clients, more importantly – the people they serve, the best diagnostic imaging systems in the world. In line with our mission to provide long and comfortable life to millions as well as good working environment for healthcare professional through high performance products using cutting edge technologies.…
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