Manager de transition

A fast-growing MedTech company specializing in Class III implantable medical devices.
The organization is driven by innovation and quality, developing cutting-edge technologies that improve patients lives.
You will join a collaborative environment where excellence, agility, and teamwork are central to the companys culture.

• Implement, maintain, and continuously improve the Quality Management System (QMS) in compliance with ISO 13485, ISO 14971, and MDR 2017/745.

• Promote the quality culture across the organization and ensure adherence to regulatory and internal requirements.

• Lead internal and external audits, management reviews, and process performance analysis.

• Oversee documentation control, CAPA management, and change control processes.

• Support risk management, product compliance, and design documentation review.

• Manage supplier qualification, audits, and yearly evaluations.

• Oversee EtO sterilization validation, bioburden monitoring, and cleanroom controls.

• Ensure conformity of production lots before release and act as the quality representative for design and development projects.

• Report to top management on QMS performance, product quality, and continuous improvement actions.

This is an exciting opportunity for an experienced Quality professional to play a key role in ensuring compliance, operational excellence, and patient safety within a high-tech medical device manufacturer.
Youll work closely with R&D, production, and regulatory teams in a dynamic and innovation-driven environment.
The position offers strong visibility and strategic impact within the organization.

• Degree in a scientific field (biotechnology, pharmacy, chemical or biomedical engineering, or similar).

• Minimum 3 years experience managing or operating within a certified QMS in the medical device sector.

• In-depth knowledge of ISO 13485, ISO 14971, MDR 2017/745, and sterilization standards (ISO 11135,

• Experience with electro-medical devices (IEC 60601, IEC is a plus.

• Skilled in CAPA, audits, risk management, and process validation.

• Fluent in English (spoken and written); French is an advantage.

• Autonomous, structured, and proactive, with strong problem-solving and communication skills.