Quality Administrative (Healthcare)

We are looking for a Product Complaint Administrative for a medical device company located in Barcelona.

Main tasks:
1. Evaluate customer feedback whether it represents a product complaint. Register product complaints in global product complaint database (EtQ Reliance).
2. Performs timely checks / screening of all incoming complaint notifications as to whether they potentially need to be reported to regulatory authorities (PAE). Escalates possibly reportable cases in line with regulatory requirements and internal rules.
3. Coordinate all complaint related activities with the stakeholders (e.g. customers, sales force, and service) in order to gather the required information. (e.g. collection complaint details from customer or service, conducting microbiological sampling of medical devices)
4. Keep close communication with the complainant, e.g. collection of additional required information and providing feedback. Ensure complainant receives adequate final complaint answer, if required.
5. Document complaint information in the respective complaint file (in EtQ).
6. Manage medical device returns to OEKG or manufacturer for technical device inspection. Including stock bookings in ERP system and return authorization.
7. Facilitates and initiates the solution for the customer (replacement, credit note, repair) in alignment with sales and service.
8. Processing of inter-company compensations.
9. Explain complaint files during audit situations.
10. Support the training of employees on the complaint process and regulatory requirements.
11. Pro-actively monitor incoming complaints and complaint process. Manages (potentially) escalating cases in the country/region in cooperation with sales, service and OEKG PMQ.
12. Focus on customer expectations in complaint processing (effort to address the complaint, flexibility to resolve issues, timely problem resolution for the customer, quality of solution)
13. Manage Field (Safety) Corrective Actions (FSN, FSCA) and product recalls in collaboration with the regional quality manager. Process the roll-out of these actions in collaboration with effected local parties, and in line with the defined processes.
14. Optionally, represent complaint management in various contexts, like participation in IT or other projects, or other special activities (e. g. change projects).

Professional education technician, bachelor or similar
Up to 2 years of experience in similar administrative tasks
Fluent english (C1)

Administración, Calidad, Healthcare