QA Customer complaints handling specialist
- 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.
Long term Project
QA Customer complaints handling specialist
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. Evaluate the complaints for potential health hazard and de...
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