Secteur: recrutement / ressources humaines
Taille: Entre 20 et 100 employés
Description de l'annonce:
You will support the required event reporting and investigation of all medical device complaint-related procedures, in accordance with applicable laws and regulations, records and evaluate complaint submissions.
You will Manage External Communication to acquire relevant complaint information, coordinate with internal departments to incorporate vital input into medical device event reports, review and provide feedback on complaint manufacturing investigation reports and ensure timely processing of complaints.
You have to involve in activities to prepare for audits and inspections ,perform root cause investigations and is involved in CAPA (Corrective and Preventive Action) activities and provide material to support post-market surveillance reports and review and close complaint files.
You will collect complaint case and process metrics to capture and generate trend reports,coordinate with other departments to provide complaint data reports as needed and participate in inter-departmental cross-functional projects.
High school diploma or equivalent (Engineer, master’s degree or equivalent).
One year related work experience.
Knowledge in ISO 13485, 9001, Global MD related QMS, Monthly Complaints KPI.
Advanced Computer Skills ,training needed for “Global Complaint Management Workflow (GCMW).
Advanced Level of English & French.