Our Client is a is an innovative medical device company based in Mont-Saint-Guibert with a Production site in the area of Liège (but also in Israël and Australia) that is currently developing a novel neurostimulation technology to treat Obstructive Sleep Apnea (OSA). The mission of the company is to provide their users, with the freedom to enjoy life to its fullest by delivering reliable, durable and harmonious solutions to treat OSA.
You are looking for a professional challenge that allows you to work in a start-up environment in order to participate to the improvement of manufacturing activities in terms of Quality?
You want to bring your expertise in terms of GMP and/or ISO 13485 environment and/or Batch Release? You want to endorse polyvalent responsibilities in order to contribute to face a scaling-up phase?
Plus One can offer you this great challenge:
Your key responsibilities:
- Production support activities :
- Production and Process Control activities
- Release of incoming materials and in-process inspections
- Release of final goods
- Non-conformances investigation
- Engineering change order and document change processes
- Clean Room Monitoring
- Calibration Monitoring
- Protocols reports
- Engineering support activities:
- Manage Documentation processes for in-house product design control and development
- Process verification and validation
- Review of Validation and Verification reports
- Management of complaints,
- Risk management
- Employee trainings
Professional skills Requirements:
- You own a Master Degree in Mechanics , Electro-Mechanics, Biomedical Engineering or Equivalent.
- You have first experience (2-5 years) in Quality activities in Manufacturing environment.
- You have at least 2 years of experience with ISO 13 485 in the highly regulated environment Medical Device industry. Knowledge of GMP is a plus.
- Your are familiar with regulatory requirements in Medical Devices industry (MDR)
- You have a demonstrated knowledge in Qualification activities and/or Batch Release
- You are able to communicate effectively with Production Team
- You are fluent in French and English - High level (Verbal and non-verbal)
Personal skills required
- Proactive and good communicator.
- Ability to work independently while within a group framework
- Self-motivated, self-maintained and able to take the initiative to solve problems
- Good organization skills and hand’s on mindset
- Leadership (possibility to lead a team within one year)
Our Client offers a full-time permanent position along with an attractive remuneration package.
The position is based in Belgium and has an international scope.
This is an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and team spirit.