Quality Manager

Rotterdam Innovation City; Netherlands; On-site; EUR 70,000 - 110,000; Full time

Job summary

Rotterdam Innovation City is seeking a Quality Manager to oversee quality assurance and regulatory compliance across our product line. You will monitor day-to-day product quality and drive improvements through guidelines and systematic improvements.

The role emphasizes MDR and ISO 13485 alignment for EU markets and involves coordinating with cross-functional teams to ensure compliance when entering new markets such as the US.

Qualifications

• Knowledge of MDR and ISO 13485 for EU market.
• Experience with quality management systems is preferred.

Responsibilities

• Oversee quality assurance processes across products.
• Ensure regulatory compliance with MDR and ISO 13485.
• Monitor day-to-day product quality and drive improvements.

Skills

Quality assurance

Regulatory compliance

Quality monitoring

Tools

Matrixreq

Odoo ERP

Job description

Responsibilities

As a Quality Manager you are responsible for the quality assurance and regulatory compliances. You monitor the quality of our products day-to-day and implement guidelines and improvement regularly.

Regulatory Requirements

For EU market, Medical device regulation (MDR) and ISO 13485 are the key to follow. Other regulatory requirements must be complied when entering new market such as US market.

Software Tools

Matrixreq and Odoo ERP are the main software tools we use to ensure quality.