Philips Quality & Regulatory Trainee in Monza, Italy
The Q&R Trainee will directly report to the Head of Q&R at Philips HealthSystems.
The main responsibilities will be :
Post-Market Surveillance activities:
Supporting the review of reports about medical devices’ adverse events and malfunction received from the factories and translation of contents (also integrated with info collected from the field)
Sending localized reports to the Ministry of Health and customer involved.
Supporting the periodic review of local work instructions with the process owners
Supporting the review of draft version of the international procedures in order to support the future deployment in the local organization
Analysis of service activity records/documents:
- Supporting the collection of info and details about activity performed in the field by the engineers, in order to verify the reportability of events to the Competent Authority.
- Supporting the collection of certifications and product documents for product registration or upon request by customers.
· Communication and problem solving skills. Ability to cooperate with different functions in the organization.
· Proactivity and Thinking out of the box
· Educational level: master degree in Biomedical Engineering.
· Fluentl English.
· Application software: Microsoft Office, Explorer.
· Recommended knowledge of the ISO standard ISO13485.
· This a 6 months stage contract