Medical Devices Complaint Manager
Our customer is one of the leading companies in the areas of intensive care. More than half of the employees work at the headquarters for development and production in Switzerland.
For the second time in a row, our customer received the Top Company award from the most important rating portal in German-speaking countries.
To support the S&M QA team for a broad portfolio of ventilation products, monitoring and recording accessories and consumables we are seeking for an individual located in Switzerland or Germany.
Your tasks :
- Receive, register, and evaluate the complaint information for acceptance or rejection and justify the decision
- Perform initial assessment for reportability and escalate complaints determined as reportable to Vigilance
- Ensure that complaint investigations are appropriately performed and documented
- Determine the need for a CAPA request based on investigation findings
- Provide the complete IMDRF rating according to the complaint investigation report
Your skills
- Education in a scientific or medical-technical direction, BSc. Level preferred
- 3+ years experience in processing complaints and performing triage and investigations, ideally in the medical device
- Speaking and writing English fluently
- Profound experience with reading and interpreting device diagnostics and troubleshooting with medical devices
- Background in Post Market Surveillance and Health Hazard Evaluation
- Proven experience in working with complaint management systems (Ky2Help, Service-Now, ETQ, MasterControl, etc.)
- Experience with intercultural teams in global matrix organization
- Recognized expertise in electronics, electromechanics and / or biomedical
- Experience with communication to local authorities
- International travel requirement up to 20%
We are looking for initiative and communicative personalities with a hands-on mentality and solution oriented mindset. We're happy if it's exciting, you step on board on this recruitment and we can discuss your application with the line manager.
Interested? We are looking forward to get in touch with you.
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