Device Quality Lead 14695

• Consultancy mission ( employee or freelance) to start around 05/2025 - until 31/12/25
• Based in Braine l'Alleud with hybrid mode

Embark on an exceptional adventure with a global biopharmaceutical company, driven by an unwavering passion to meet the crucial needs of people affected by serious diseases.

We are looking for a Device Quality Lead to join the team. This position is crucial for the development and quality management of medical devices, particularly those integrated into combination products such as auto-injectors and pen injectors

Main Tasks:

- Development and Monitoring of Medical Devices: Support the development and design control phases, following key standards such as ISO 13485, ISO 14971, and ISO 11608.

- Supplier Management: Ensure that internal design control procedures are followed by suppliers.

- Risk Management: Implement risk management policies and monitor potential non-conformities during development and clinical phases.

- Commercial Support: Monitor products in the commercial phase, manage material changes, and conduct necessary tests.

- Coordination and Compliance: Ensure good coordination and compliance during the integration of existing solutions.

- Document Review: Participate in document reviews, including the design history file, to ensure document compliance and consistency.

- Process Improvement: Propose efficiency improvements in existing processes.

Must-Have Skills:

- Expertise in the development and quality management of medical devices.

- In-depth knowledge of ISO 13485, ISO 14971, and ISO 11608 standards.

- Experience in supplier management and design control.

- Risk management skills.

- Proficiency in English.

- Technical aptitude to understand and contribute beyond compliance.

- Experience in a regulated environment (ISO 9001).

Nice-to-Have Skills:

- Knowledge of US and European regulations.

- Experience with auto-injector and pen injector technologies.

- Ability to propose process improvements.

- Proficiency in French.

- Experience in the pharmaceutical or biopharmaceutical sector.

- Experience in supply management and audit management.

- Experience with primary packaging and containers.

Offer :

For this position of Device Quality Lead , we offer an attractive salary with the following benefits :

• Work life balance
• Group insurance
• Hospitalization insurance
• 7 euros meal voucher per day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training to stay at the forefront of innovation

A rate as a freelancer is also possible.