- Ensures processes are in place to manager customer feedback
- Ensures US market complaints are processed in a timely manner and performs appropriate follow ups
- Provide guidance for customer facing teams on complaint handling processes
- Ensure ongoing issues are monitored and escalated internally as necessary
- Tracking and trending of US product feedback to increase visibility and tracking of issues/emerging issues
- Create and maintain Quality Assurance documentation (SOPs, WIs, template, etc.).
- Manage global feedback for retail organization
- Manage issue escalation globally for product related topic
- Support during Internal/external Audits for backroom, front room, SME, etc.
- Prepare and manage local management reviews and associated processes
- Bachelor's Degree required, preferably in Engineering
- At least 3-5 years’ experience in Quality, Quality Management Systems within regulated industry; preferably medical devices.
- Knowledge of Quality Standards and Quality Systems Requirements for Medical Devices in the US
- US FDA inspection and ISO 13485 audit experience preferred.
- At least 5 years’ experience in working in a team