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Quality Assurance Engineer – F/H

Présentation société

Brightflow is an innovative medtech startup located on the banks of the Seine in the 13th arrondissement of Paris.
Our team of 30 passionate experts is developing the first implantable, surgery-free heart pump for the right heart, a breakthrough innovation designed to improve patients’ quality of life and redefine cardiac care.

Brightflow is an innovative Medtech startup located on the banks of the Seine in the 13th arrondissement of Paris.
Our team of 30 passionate experts is developing the first implantable, surgery-free heart pump for the right heart, a breakthrough innovation designed to improve patients’ quality of life and redefine cardiac care. To support our growth and strengthen our Quality department, we are seeking a Quality Assurance Engineer.

Key Responsibilities:

• Contribute to the definition, implementation, monitoring, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, ISO 14971, and other applicable standards.
• Oversee documentation management activities to ensure accuracy, traceability, and regulatory compliance.
• Provide support to the R&D department in design and development activities, ensuring that deliverables meet relevant standards and regulatory requirements.
• Design and monitor process performance indicators for assigned activities, driving quality improvements.
• Participate in internal and external audits.
• Support the implementation of corrective and preventive actions arising from nonconformities or audit findings.

Provide training and guidance to cross-functional teams on key processes within the Quality Management System.

Descriptif du profil

Education: Bachelor’s or master’s degree in Biomedical Engineering or equivalent.

Experience: 5 years of experience in a Quality position in the medical device industry, preferably involving Class III devices or within the cardiovascular field.

Skills:

• Knowledge of standards and regulations applicable to medical devices: ISO 13485, ISO 14971, IEC 62304, Medical Device Regulation 2017/745, etc.
• Experience in a startup environment is a plus.
• Proficiency in Microsoft Office.
• Organized, structured, and analytical mindset with problem-solving skills.
• Excellent communication skills, both written and verbal.
• Team-oriented and adaptable to a fast-paced, innovative environment.
• Languages: Professional working proficiency in English and French.

Postuler

Linda Boulaire
contact@brightflow.com