Our Client is a is an innovative medical device company based in Mont-Saint-Guibert (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 development of new manufacturing activities?
You want to bring your expertise in the installation of new manufacturing activities in GMP and/or ISO 13485 environment? 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:
- Managing (including hiring) a team of clean room operators and electronics integrators
- Improving production Yield and reporting on availability of finished products for clinical and commercial use.
- Determining most efficient uses of available resources, including equipment and labor
- Educating employees to ensure understanding and GMP/other regulatory compliance
- Planning, co-ordination and control of manufacturing processes
- Improving, developing processes, production equipment and production facilities
- Writing, reviewing and updating production documentation including SOPs, master batch records, change controls, deviations, reports, risk assessments, supplier approval
- Analyzing problems, identifying root causes and corrective and preventive actions
- Accountability for achieving production targets while maintaining cost controls
Professional skills Requirements:
- At least 5 years of cGMP in pharmaceutical or medical device manufacturing at management level
- Experience with clean rooms and ISO13485,
- Track record of improving manufacturing yield and cost reduction
- Engineering qualification or equivalent experience
- Experience of lean/six-sigma principles preferred
- Injection molding expertise preferred
Personal skills required
- Proactive, creative and innovative
- Ability to work independently while within a group framework
- Punctual with defined timelines (Organizational skills)
- Excellent proficiency in French and English (verbal and written)
- Effective communication skills
- Self-motivated, self-maintained and able to take the initiative to solve problems
- Ability to motivate employee, strong people leadership
- Committed to follow company policies and procedures, follow cGMP and other regulatory requirements.
Our Client offers a full-time permanent position along with an attractive remuneration package.
The position is based in Belgium (Mont-Saint-Guibert (HQ) and Liège (Production Site)) and has an international scope.
This is an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and team spirit.