QA Customer complaints handling specialistMichael Page

Our client is a Swiss leader in the innovative medical devices sector.

* Receiving, reviewing, and processing customers feedback while using Good Documentation Practices.
* Processing complaints through classification of complaints, contact and product follow ups, maintaining investigation records and all other supporting documentation, and complete/assign additional actions as necessary to close the complaint.
* Ensure complaints are processed thoroughly and in a timely manner in compliance with internal procedures and metrics.
* Chair the Complaint Handling Unit (CHU) meetings.
* Evaluate the complaints for potential health hazard and determine if complaints require escalation.
* Ensure complaints requiring contact responses are properly addressed and response is documented in the complaint file.
* Request information from the contact/field related to complaint including the return of product(s).
* Review's complaint investigation to ensure investigations meet procedural requirements.

* Bachelor's degree in Science, Engineering, Biotechnology, Quality Management or Cell Therapy (preferred).
* At least 6 months complaint handling experience in a medical device establishment preferred.
* Preferred ability to apply FDA 21 CFR 820, ISO 13485, ISO 9001 and other relevant regulation/standard relating to complaint processing.
* Must be detail oriented. Able to detect errors and ensure accuracy of complaint file documents and analyses.
* Critical thinking and problem-solving skills.
* Ability to work and communicate with others in a professional and effective manner, within a cross-functional team-oriented environment.
* Excellent verbal/written communication skills in French and English required.