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Oferta pracy
Documentation Specialist
SMARTMEDICS sp. z o.o.O firmie
- Warszawa, mazowieckie
- ogłoszenie wygasło 3 lata temu
- umowa o pracę, umowa zlecenie, kontrakt B2B
- pełny etat
- starszy specjalista (Senior)
Twój zakres obowiązków
- Creating documentation that meets the regulatory requirements
- Keeping up-to-date documentation with the regulatory requirements around documentation, and implements changes if necessary, verifying versions, recording, accepting, storing and archiving
- Overseeing technical documentation changes during prototype, production implementation and mass production phases
- Taking care of documentation standards.
- Coordinating cooperation on documentation with R&D engineers, process engineers and project managers.
- Supervising data integrity in systems and manufacturing applications.
- Identifying documentation problems, initiating and coordinating corrective, preventive and improvement actions.
- Training of colleagues on the requirements around documentation
- Participation in internal audits and external regulatory inspections
Nasze wymagania
- Higher education - technical faculty
- Experience in a similar position
- Understanding and working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Part 820, ISO 13485, ISO 9001.
- Ability to interpret regulatory documents (standards, regulations, directives, laws)
- Ability to read technical drawings and schematics
- Familiarity with record-keeping policies and practices.
- Fluent in English: verbal and written
- Goal-oriented attitude, responsibility and commitment to performed tasks
To oferujemy
- Work in a creative team and friendly atmosphere
- Full of challenges
- Work on international projects and a possibility to gain professional experience within multicultural environment
- Cooperation with positive and experienced people – opportunity to self-development and knowledge-sharing
O nas
SmartMedics is a dynamic technological company operating in development and production of telemedicine devices. SmartMedics products contribute to the improvement of heart disease diagnostics using the latest clinical research results, advanced algorithms and sustainable and low-emission production of printed electronics.
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Documentation Specialist, Aleja Krakowska 106, Warszawa