miércoles, 9 de septiembre de 2015

Certificat de Qualitat - (Switzerland) Junior Engineer - Case Investigation

(Switzerland) Junior Engineer - Case Investigation

: Roche
: For our Case Investigation & Resolution department supporting the cobas® 6800/8800 and cobas p 680 Systems (Hardware, Software and workflows) we are looking for an Engineer to join our team. In this exciting position in an international environment, you will be covering the following key responsibilities:
Assumes full accountability for the management of individual cases (Inquiries, Complaints, PCCs) in the area assigned according to regulatory and ISO Quality system requirements and needs of the Country Organizations in a timely manner
Collects all relevant data and evaluates each escalated complaint to determine if investigation is needed
Communicates evaluation/investigation results to Affiliates and other global interfaces
Collaborates with investigation teams to ensure an efficient approach for root cause analysis
Collaborates with Business Area and global functions, ensure appropriate measures from cases are derived
Communicates relevant information to the Country Organizations in a timely mannerRequisits
The successful candidate brings the following with them:
Academic degree in Engineering, IT, Biotechnology or equivalent professional experience
0 ? 3 years of work experience in the area of medical technology in either 1st or 2nd level system support, or Medical Device R&D, or Operations related functions
Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management desired (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)
Technical orientation with robust organization skills, problem solving, troubleshooting capabilities and ability to learn new systems and technologies
Strong customer service orientation and ability to handle multiple cases in parallel
High sense of urgency to drive cases to a timely resolution and closure
Positive attitude, good sense of humor and ability to work in a team environment
Excellent communication, interpersonal
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