Quality & Regulatory Architect — MedTech Startup (Hybrid)

HR One Group; Antwerpen; Sur place; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Competitive salary and benefits

Hybrid work model

Opportunity to shape a QMS from the ground up

Résumé du poste

HR One Group seeks a Quality Assurance Specialist for a medical software company in Antwerp. You will support the Quality Management System, ensuring documentation and compliance in a fast-paced startup environment.

This hands-on position involves working closely with the Chief Operating Officer and the development team, integrating quality practices into the agile software cycle, and having direct visibility into product development.

Qualifications

• 2 to 4 years of hands-on QA experience in the medical device industry.
• Solid working knowledge of ISO 13485 with practical application in daily operations.
• Experience writing and managing QMS documentation, including SOPs and work instructions.

Responsabilités

• Draft, review, and maintain QMS documentation including SOPs and work instructions.
• Support the operation of the company’s software-based QMS designed for agile medical device development.
• Conduct internal audits and prepare for regulatory submissions.

Connaissances

QA experience in medical devices

Knowledge of ISO 13485

QMS documentation management

Strong communication skills in English

Description du poste

HR One Group seeks a Quality Assurance Specialist for a medical software company in Antwerp. You will support the Quality Management System, ensuring documentation and compliance in a fast-paced startup environment.

This hands-on position involves working closely with the Chief Operating Officer and the development team, integrating quality practices into the agile software cycle, and having direct visibility into product development.