Quality Assurance / Regulatory Manager  

Medical Devices

This is your chance to work with innovative products and be part of something that will have a real impact in the Medical Devices industry.
You will be working closely with the engineers to develop products. That will also be an opportunity to follow the whole process from A to Z and have your word!

Your responsibilities

The QA/RA Manager coordinates and manages all quality control activities of a process to ensure that materials, processes and finished products meet and respect established standards. Another aspect of its role is the introduction of improvement initiatives.

You will define above all the fundamental qualitative / regulative characteristics that the product offered must have in order to be marketable. On the basis of the elements identified, you will adopt a quality management system to ensure that the final product corresponds to the desired technical specifications.

You draw up the necessary procedures to ensure that quality standards are achieved in all phases of processing. You will plan the control activities, check and manage the system of documentation of the different stages, in order to verify that the processes comply with the standards in force at national and international level.

You will work together with the other departments to ensure that the quality control procedures are put into practice. If necessary, specific training courses are planned for the team responsible for the controls.

You will be also responsible for establishing a system of indicators to monitor performance and ensure a constant level of quality over time. You will collect data from all control systems and from customer feedback to identify deficiencies and areas for improvement.

When it is found that standards have not been met, you will have to take the necessary corrective actions to resolve the situations of non-compliance, working in close contact with the managers and staff of the different areas of the company concerned.
In addition, you communicate with the technicians of the client companies and the certifying inspectors of the external bodies that verify the processing processes.

You will act in Quality Assurance and Regulatory Affairs activities such as, but not limited to:

• Quality Management System implementation
• Standards watch and GAP analysis
• Audits
• Compilation of documentation for notified bodies, FDA, competent authorities
• Promote a quality culture throughout the company

Your qualifications

• Min. 4 years of relevant experience in medical devices QA/RA functions with ability to understand and implement a f research & development quality system (CE certification, etc.)
• Knowledge of QMS
• Ability to support / actively participate in the implementation of the quality elements, corrective measures or improvements envisaged.
• Good understanding of medical devices regulatory environment (MDD 93/42, MDR)
• Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards
• Work cross-functionally in identify and resolve various quality issues, participate in CAPA management
• Thorough understanding of project/program management techniques and methods

You are

• Passionate about life sciences, technology and innovation
• Quality and customer-service oriented
• Ability to support / actively participate in the implementation of the quality elements, corrective measures or improvements envisaged.
• Excellent problem-solving ability. Result driven.
• Outstanding communication and organizational skills.
• Capacity to integrate numerous and complex info in order to propose quick and high quality solutions. Flexibility in a strongly changing environment.
• Collaboration-oriented. Team player.
• Focused on details
• Excellent problem-solving ability. Result driven.
• Strong communication and organizational skills
• Teamleader – People Management
• Autonomous & quick learner
• Flexible & open-minded
• Fluent in English and French or Dutch

Offer & benefits

• The opportunity to contribute to the development of products that will improve or save people's life
• A valorizing job within an ambitious and growing company in a booming industry
• A great team of enthusiastic people led by passionate experts in MedTech
• A nice working environment in Brussels, very close to the forest of Soignes, a park, nice shops and restaurants, public transport connections
• And of course, a good salary package and extra benefits!