Complaint Specialist (CS)

FIZE Medical is a growing medical device company that offers the first platform technology to remotely monitor and manage patients with an indwelling Foley catheter, providing unprecedented safety to both patients and their caregivers.

The Complaint Specialist (CS) handles complaints from opening to closure. Manages complaint database and trending, ensures compliance with QMS and regulatory requirements (ISO13485, ISO14971, EU MDR, 21 CFR). Non-managerial, Technical | Reports to Head of QA&RA

Triggers and facilitates related processes, including:

• Failure investigation
• Medical device reporting
• CAPA
• Post-market risk assessment (HHE)
• Customer communication
• Correction/removal review board

Prepares complaint data for management reviews, audits, and inspections.

Qualifications:

• Bachelor’s degree (sciences/engineering); biomedical engineering is an advantage
• 3+ years in medical device complaint handling
• Good understanding of regulations and standards affecting medical devices: at a minimum, ISO13485
• Fluent in English
• Strong coordination, problem-solving, and communication skills

Please submit your CV to [email protected]