Operations Quality Engineer (OpsQE)

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 Operations Quality Engineer (OpsQE) represents QA&RA in operations and production. Drives quality activities on the production floor, ensures compliance with ISO 13485, FDA, and company QMS. Ensures product quality, process control, and continuous improvement throughout production. Non-managerial, Technical | Reports to Head of QA&RA

Key Responsibilities:

• Drive QA&RA activities in operations, production, purchasing, and warehousing
• Maintain compliance with regulatory and QMS requirements
• Implement and monitor PV, EQ, control plans, pFMEA
• Support IQ/OQ/PQ protocols and CAPA investigations
• Define, monitor, and act on KPIs
• Prepare for audits, perform internal pre-audits
• Support supplier quality (SCARs, audits, monitoring)

Requirements:

• B.Sc. in sciences/engineering
• 5+ years in Operations QA/Engineering
• Good understanding of regulations and standards affecting medical devices: at a minimum, ISO13485
• Experience with process validation, cleanrooms, and supplier quality
• Fluent English, strong coordination and communication skills

Please submit your CV to [email protected]